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Speaker 1: Overall, the FDA has had a number of spectacular hits

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Speaker 1: and pretty notable failures, and it is worth asking how

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Speaker 1: good of a job is the agency doing and are

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Speaker 1: they living up to their mandate to protect the public health.

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Speaker 1: My boss at the time said Richard, we don't have

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Speaker 1: to solve problems. All we have to do is appear

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Speaker 1: to solve problems. Welcome to Calling Bullshit, the podcast about

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Speaker 1: purpose washing, the gap between what an organization says they

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Speaker 1: stand for and what they actually do and what they

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Speaker 1: would need to change to practice what they preach. I'm

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Speaker 1: your host time onto you, and I've spent over a

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Speaker 1: decade helping organizations define what they stand for, their purpose

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Speaker 1: and then help them to use that purpose to drive

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Speaker 1: transformation throughout their business. Unfortunately, at a lot of institution today,

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Speaker 1: there's still a pretty wide gap between word. Indeed, that

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Speaker 1: gap has a name, bullshit. But, and this is important,

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Speaker 1: we believe that bullshit is a treatable condition. So when

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Speaker 1: our bullshit detector lights up, we're going to explore everything

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Speaker 1: the organization should do to fix it. There was a

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Speaker 1: time in the not too distant past when cocaine was

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Speaker 1: marketed to children and literal snake oil was sold as medicine,

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Speaker 1: a time when sawdust was put into food as filler,

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Speaker 1: and when rats were ground up with the beef, and

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Speaker 1: it was all perfectly legal. Food and drugs were sold

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Speaker 1: in a completely unregulated market until President Theodore Roosevelt signed

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Speaker 1: into law the Food and Drugs Act of nine six,

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Speaker 1: giving the executive branch the power to regulate food and

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Speaker 1: drugs and thus creating what we now call the f

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Speaker 1: d A. Today, the Food and Drug Administration has an

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Speaker 1: expansive jurisdiction regulating things raging from microwave ovens to cat

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Speaker 1: nip to ibuprofen and beyond, way beyond chew. On this

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Speaker 1: the FDA regulates twenty cents of every dollar that you

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Speaker 1: spend to cover such a broad water front. They employ

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Speaker 1: eighteen thousand people that work across several inter agencies, including

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Speaker 1: the Center for Drugs, Biologics, Devices, Veterinary Medicine, Food Safety

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Speaker 1: and Nutrition, and tobacco. Their formal purposes a few paragraphs long,

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Speaker 1: but on the homepage of their website they have a

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Speaker 1: phrase that nicely captures the spirit of it, and it

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Speaker 1: really Today, as in the past, the FDA strives above

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Speaker 1: all else to safeguard the health and well being of

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Speaker 1: the American people. That is a monumentally important purpose, one

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Speaker 1: in which the stakes for all of us are high. However,

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Speaker 1: if you've been listening to the news lately, it seems

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Speaker 1: like the f d A is falling pretty short of

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Speaker 1: living up to it. Speaking about the epidemic of youth

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Speaker 1: use of e cigarettes, it retrospects the FDA should have

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Speaker 1: acted center nationwide of baby formula stock is gone. Part

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Speaker 1: of the blame for a lot of these shortages rest

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Speaker 1: at the feet of the f d A. The FDA

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Speaker 1: first approved OxyContin. Since then, more than five hundred thousand

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Speaker 1: people have died from opioid related overdoses. We've actually encountered

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Speaker 1: the FDA twice before, first when discussing their role regulating Jewel,

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Speaker 1: and again while researching Perdue Pharma for a potential episode.

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Speaker 1: The FDA was certainly a character in the first Jewel episode,

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Speaker 1: but when we checked in on Jewel again this season,

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Speaker 1: it was clear that the f d A shared a

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Speaker 1: lot more of the blame for the damage caused by

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Speaker 1: Jewels unregulated product, and so we decided to aim our

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Speaker 1: BS detectors directly at the f d A. Starting with

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Speaker 1: picking up the strange case of Big Tobacco, Vaping and Jewel. Okay, folks,

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Speaker 1: I am very excited to introduce Lauren Etter for her

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Speaker 1: second time on the show. Lauren, thank you for being

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Speaker 1: here and welcome back to calling Bullshit. Thanks for having

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Speaker 1: me tie great to be here. Lauren is the author

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Speaker 1: of the Devil's playbook, Big Tobacco, Jewel and the Addiction

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Speaker 1: of a New Generation. But before we continued the conversation

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Speaker 1: with Lauren, let's catch you up on the escalating story

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Speaker 1: of the regulator and the company with a b S

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Speaker 1: roundtable recap. Okay, So, Jewel Labs launched its Jewel E

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Speaker 1: cigarettes as a smoking cessation device in it was actually

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Speaker 1: effective and had the potential to help smokers get off cigarettes.

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Speaker 1: But Jewel was funded by venture capitalists with a growth

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Speaker 1: at all costs mindset, which led them to target kids,

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Speaker 1: the demographic most susceptible to picking up a smoking habit,

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Speaker 1: thus sparking a new youth nicotine epidemic total BS. But

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Speaker 1: at the time the cigarettes were totally unregulated. Finally, in

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Speaker 1: the FDA began regulating the cigarettes as tobacco products and

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Speaker 1: requiring manufacturers to submit applications to be on the market.

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Speaker 1: And guess what, Jewel Labs didn't get around to submitting

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Speaker 1: their application to the FDA until July, all while they

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Speaker 1: were still selling Jewel more bs. You would think the

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Speaker 1: story ends here, but it doesn't. It then took the

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Speaker 1: FDA two more years to review Jewels application, all the

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Speaker 1: while jewels are still being sold. Finally, in June of

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Speaker 1: twenty two, the f D announcer decision to deny Jewel

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Speaker 1: Labs application, essentially banning the e cigarette. Their reasoning Jewel

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Speaker 1: did not provide enough scientific data to show that their

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Speaker 1: products were not harmful. Not surprisingly, Jewel Labs immediately sued

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Speaker 1: and within a few days was granted an emergency stay,

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Speaker 1: allowing them to keep their products on the market. And

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Speaker 1: now the FDA has walked back their decision and it's

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Speaker 1: currently re reviewing the application, leaving Jewel. You guessed it

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Speaker 1: still on the market, and that you're round. I think

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Speaker 1: we have different internet connections and that's your round table recap.

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Speaker 1: The FDA website says, today, as in the past, the

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Speaker 1: FDA strives above all else to safeguard the health and

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Speaker 1: well being of the American people. So first, I just

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Speaker 1: wanted to ask you, how do you think they're doing

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Speaker 1: at meeting their mission or achieving their purpose? I would

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Speaker 1: say just in general that with tobacco, for many years,

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Speaker 1: until the early two thousands, the agency didn't have any

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Speaker 1: jurisdiction over the tobacco industry. It was a completely unregulated market.

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Speaker 1: And it was only after the Master Settlement Agreement and

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Speaker 1: after the tobacco companies has gotten crushed in that whole ordeal.

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Speaker 1: When you know, for years Congress tried to figure out

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Speaker 1: how to regulate tobacco. The Supreme Court even at one

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Speaker 1: point said they didn't have jurisdiction. So this has been

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Speaker 1: an issue like where should the tobacco industry sit doesn't

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Speaker 1: make sense for the f d A to regulate this industry,

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Speaker 1: But for years there's industry was totally unregulated. So I

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Speaker 1: think that there's a lot of questions worthy of tasking

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Speaker 1: about the f d A and certainly about their role

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Speaker 1: in the regulation of tobacco. You may remember that we

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Speaker 1: we score organizations on their level of BS. Would you

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Speaker 1: be comfortable giving the f d A a score even

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Speaker 1: as it relates to the Jewel situation of zero to

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Speaker 1: in terms of gaps between word indeed. So if you

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Speaker 1: look at what the agency is doing in the top

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Speaker 1: back the overall kind of tobacco space and their efforts

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Speaker 1: to implement a harm reduction framework, they're actually making strides.

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Speaker 1: My issue is, I don't feel like the FDA has

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Speaker 1: enough resources to police the kind of illicit sale of

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Speaker 1: the product to keep it out of the hands of

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Speaker 1: the youth. They're just a very underfunded agency, especially the

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Speaker 1: tobacco products. And so if you're looking at the twin

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Speaker 1: problems of adult smoking and youth nicotine addiction, I feel

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Speaker 1: like they they are focusing quite a bit on the

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Speaker 1: adult smoking issue and then the youth nicotine addiction issue.

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Speaker 1: I don't know if I have enough confidence that they're

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Speaker 1: going to be able to ultimately keep this highly addictive

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Speaker 1: product out of the hands of kids, which is ultimately

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Speaker 1: the goal to stop a new generation from becoming addicted.

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Speaker 1: So can I give them a score? Um? I just

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Speaker 1: don't know if I feel comfortable settling on a on

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Speaker 1: a number, Yeah, that's okay, but it's it's definitely not

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Speaker 1: the best number. Zero right there bumbling their way through this,

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Speaker 1: and let's just say, with the best of intention, right,

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Speaker 1: they have failed to protect America's youth so far from vaping,

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Speaker 1: which is, at the end of the day, an extremely

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Speaker 1: efficient delivery system for what ought to be a controlled

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Speaker 1: substance in my view, right, But the FDA is constantly

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Speaker 1: barraged with this flood of new products, and they're constantly

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Speaker 1: on their heels responding to these like rapidly innovating markets.

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Speaker 1: That makes it very difficult for them to contain this, again,

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Speaker 1: highly addictive product that's being sold at seven elevens, and

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Speaker 1: you know corner stores around the country that not all

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Speaker 1: of them have the greatest I D checking abilities. So

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Speaker 1: I admit it's a very difficult task for them to do.

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Speaker 1: I think it should be one of the most important

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Speaker 1: tasks that they undertake, and I know that they're taking

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Speaker 1: it seriously. I'm just concerned that they might not have

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Speaker 1: enough resources to adequately keep these highly addictive products out

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Speaker 1: of the hands of young people. Is the FDA's lack

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Speaker 1: of resources the reason they fumbled through regulating e cigarettes

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Speaker 1: and jewel in particular. Lauren thinks so, or at least

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Speaker 1: she thinks it's a significant part of it, and although

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Speaker 1: she deferred on giving them a B S score, she

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Speaker 1: does believe the FDA is making strides, no doubt, it

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Speaker 1: is an incredibly challenging undertaking. But if your purpose is

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Speaker 1: to safeguard the health of the American people and a

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Speaker 1: new generation gets addicted to nicotine on your watch, it's

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Speaker 1: definitely a harbinger of bullshit. But maybe the Center for

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Speaker 1: Tobacco Products is an outlier considering the FDA covers so

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Speaker 1: much ground, I'm going to reserve judgment and see what's

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Speaker 1: cooking at their second biggest interagency, the Center of Food

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Speaker 1: Safety and Applied Nutrition. With food specific we're trying to

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Speaker 1: do a little more because we don't want to just

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Speaker 1: make food safe. We want to give consumers information that

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Speaker 1: helped them to choose a healthier diet. Richard Williams worked

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Speaker 1: at the FDA for nearly three decades, and he left

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Speaker 1: the Center for Food Safety and Applied Nutrition with a

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Speaker 1: bad taste in his mouth. I think the big thing

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Speaker 1: was as I approached the end of my twenty seven years,

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Speaker 1: it occurred to me in all those years is that

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Speaker 1: most of what we had done had not succeeded. And

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Speaker 1: so the more I thought about it, the more I thought, well,

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Speaker 1: what actually happened? What went wrong? And I thought maybe

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Speaker 1: if I could write a book about it, we can

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Speaker 1: start changing things and and actually solving things for consumers.

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Speaker 1: Richard's book Fixing Food and f D A Insider Unravels

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Speaker 1: the myth and the Solutions, is an eye opening account

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Speaker 1: of his tenure at the organization, beginning when he was

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Speaker 1: hired as their very first economic analyst. You can blame

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Speaker 1: it on President Carter. President Carter was the first one

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Speaker 1: who said we need some economic thinking in these particularly

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Speaker 1: social regulations. More and more presidents begin insisting that we

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Speaker 1: do these things and that we take take them into

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Speaker 1: account so we can make better decisions. Let's talk about

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Speaker 1: your job and some of the eye opening parts of

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Speaker 1: your book, because you, it sounds like, walked into that

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Speaker 1: job with the best of intention. You wanted to help

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Speaker 1: the I achieve its mission of making people safer. One

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Speaker 1: of the first assignments that you had was to do

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Speaker 1: a cost benefit analysis on lead acetate in men's hair dye.

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Speaker 1: I wondered if you would tell us that story. Sure,

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Speaker 1: that was the first one just assigned to me. All

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Speaker 1: I had to go by was the executive order and

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Speaker 1: what I knew from from being an economist. So I

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Speaker 1: jumped into it and found out that this was basically

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Speaker 1: the thing that you put in your hair, and over

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Speaker 1: time it takes the great away. Richard wanted to know

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Speaker 1: of using lead acetate could cause skin cancer, and after

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Speaker 1: a deep dive into the toxicology, he found that the

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Speaker 1: risk was near zero, thus there was no benefit to

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Speaker 1: banning the drug. There was, however, a high cost to

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Speaker 1: taking it off the market. It was the only product

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Speaker 1: of its kind available, so without it, gray haired men

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Speaker 1: would have no alternative, I mean, other than living with

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Speaker 1: the fact that their hair was great. I turned into

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Speaker 1: my analysis. We didn't think a thing about it until

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Speaker 1: a couple of weeks later a young woman had come

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Speaker 1: down from the center director's office and she said, this

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Speaker 1: is great. Now we need you to do the other one.

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Speaker 1: And I said, what other one? She said, well, you

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Speaker 1: said that benefits were lower than the cost and if

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Speaker 1: we decide not to do anything about let acitate that

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Speaker 1: will work. But we want you to do one that

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Speaker 1: shows the exact opposite, that the benefits succeed the costs,

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Speaker 1: that it does costs cancer. And I'm like, well, no,

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Speaker 1: that wouldn't be honest. I'm not going to do that.

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Speaker 1: And she said, you don't understand. This is an order,

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Speaker 1: you know, from the sixth floor. And I said, no,

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Speaker 1: I'm not going to do that. I didn't hear anything

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Speaker 1: more about it. A few weeks later, I was in

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Speaker 1: our first my first training class where I was getting

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Speaker 1: my introduction to FDA, and the deputy Center director was

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Speaker 1: in there, and at lunch, I went up and I said,

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Speaker 1: you know, a funny thing happened to me, and I

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Speaker 1: explained the situation, and he said that order came from me,

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Speaker 1: and you're going to do it or you're going to

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Speaker 1: be fired. And I said something really stupid. I just

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Speaker 1: made this up on the spot. I said, I'm not

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Speaker 1: an economic prostitute. And he said, then you were fired

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Speaker 1: and you are going to be leaving this agency. And

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Speaker 1: so I went back to my office. I'm like, should

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Speaker 1: I start packing up my stuff? I didn't know. And

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Speaker 1: then nothing ever happened. He apparently decided it would be

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Speaker 1: a bad idea to fire over that kind of thing.

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Speaker 1: But that was just the first time I was threatened

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Speaker 1: with being fired. I mean, good on you that you

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Speaker 1: did not gave to that pressure. But it sounds like

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Speaker 1: that this was not an isolated occurrence. Were there other

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Speaker 1: instances where you were asked to essentially compromise your integrity

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Speaker 1: for twenty seven years. There were other instances. Was it

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Speaker 1: was it never stopped. That is incomprehensible to me, and

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Speaker 1: it's terrible. And so, for the first time in my life,

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Speaker 1: decided to become political with a small p like a

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Speaker 1: bureaucrat politician operator, which you have. Yeah, sadly, Well, so

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Speaker 1: let's let's follow that threat a little bit, because I

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Speaker 1: assume that, let's assume the best of people. Assume that

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Speaker 1: people who were feeling the pressure above you in the organization,

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Speaker 1: we're feeling it from other entities. You know, in your book,

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Speaker 1: you go into the FDA spending a lot of energy

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Speaker 1: responding to influence from just an incredible variety of stakeholders.

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Speaker 1: There's you know, the executive branch, there's Congress, there's courts,

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Speaker 1: there's press, private industry, activists, academics. Can you help us

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Speaker 1: understand the FDA's relationship with some of those stakeholders? Sure,

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Speaker 1: I mean, you know, first of all, you have to

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Speaker 1: start understanding one thing. FDA has been around since nineteen

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Speaker 1: o six, and they have continued to accumulate literally power

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Speaker 1: such that one off there said that in the twentieth century,

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Speaker 1: there was no regulatory agency in the world that was

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Speaker 1: more powerful than f DA, and that's because they're very

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Speaker 1: good at what they do. So if you think about it,

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Speaker 1: they work for the president, and the presidents are supposed

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Speaker 1: to oversee them, but every president, Republican and Democrat, has

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Speaker 1: said it's nearly impossible to control the administrative state. That is,

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Speaker 1: all the agencies that they oversee. There are hundreds of

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Speaker 1: thousands of employees. They all have their own little agendas,

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Speaker 1: and it's very, very difficult for the presidents to do anything.

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Speaker 1: Um So that's a problem. Congress they just don't oversee FDA.

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Speaker 1: They're afraid of f d A and um so there's

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Speaker 1: not a lot of oversight. They're interesting, Why is Congress

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Speaker 1: afraid of the f d A. Well, FDA has very

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Speaker 1: complex issues, very hard for Congress. People are really busy,

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Speaker 1: you know, with lots and lots of things, mostly getting

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Speaker 1: reelected and raising money. They don't have a lot of time,

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Speaker 1: and their stats aren't very good at overseeing these complex issues.

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Speaker 1: I get it, but it means that FDA is kind

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Speaker 1: of more free to do what they want, so they

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Speaker 1: hold Congress at bay the courts have up until recently

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Speaker 1: and generally will give them deference to how they interpret

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Speaker 1: their statutes. Then they have other people, academics they generally

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Speaker 1: give grants to that kind of buys them off. And

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Speaker 1: then when they go into Congress to ask, you know,

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Speaker 1: which they do every year, for more money, they actually

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Speaker 1: have large food firms going and testifying and saying, yeah,

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Speaker 1: FDA should get more money. There's a reason for that.

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Speaker 1: Large firms usually get regulations that are easy for them

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Speaker 1: to comply with but hard for small firms, so it

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Speaker 1: puts their small competitors at a disadvantage. I want to

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Speaker 1: go into that issue a little bit later, the issue

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Speaker 1: of big companies versus small companies, because that that feels

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Speaker 1: like an important topic. But before we go there, let's

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Speaker 1: talk about one other constituency, consumers and where they rank

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Speaker 1: in that higher are key. I think consumers and small

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Speaker 1: businesses both are at the bottom. When I first came

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Speaker 1: into f d A, you know, I truly believe in

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Speaker 1: what we're trying to do. I thought these are important issues,

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Speaker 1: and over time I found out well, initially when I

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Speaker 1: got there, I was told this that this actually happened

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Speaker 1: with the let acetate rule. I said, this rule won't

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Speaker 1: do anything. Why are we doing it? And my boss

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Speaker 1: at the time said, Richard, we don't have to solve problems.

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Speaker 1: All we have to do is appear to solve problems.

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Speaker 1: We have to do something about it. And that never

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Speaker 1: left me, and I noticed more and more that was

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Speaker 1: the case once we passed the regulation. No matter what

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Speaker 1: the regulation did, it didn't matter. It looked like we

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Speaker 1: had addressed the problem. And that and that leaves consumers

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Speaker 1: and public health in in in last place, if you will,

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Speaker 1: what a mess. Okay, So let's talk about some of

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Speaker 1: the you know, in your view, the biggest and most

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Speaker 1: dangerous problems that face consumers today that the FDA is

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Speaker 1: responsible for. And we can live within the domain of food,

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Speaker 1: but feel free also to talk about stuff outside of food. Yeah. Well,

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Speaker 1: I do think it's obesity. I think that is probably

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Speaker 1: the number one and it's going to get worse. You know,

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Speaker 1: there was a harvest study that projected that by the

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Speaker 1: end of this decade, which is only eight years away,

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Speaker 1: half of this country will be obese. Um FDA plays

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Speaker 1: a role in that with food labeling. Food labeling has

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Speaker 1: not worked, It's not going to work. It's really not

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Speaker 1: going to be the answer. Putting calories on foods hasn't

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Speaker 1: really changed anyone's behavior as far as we can tell,

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Speaker 1: sticking with obesity, and I don't think you you made

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Speaker 1: this connection overtly in the book, But one of the

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Speaker 1: impressions that I've gotten both from you know what we've

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Speaker 1: learned from your book and also other research that we've done,

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Speaker 1: is that intended or not, the combination of the industrialized

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Speaker 1: food system where people eat a diet and combine that

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Speaker 1: with a for profit healthcare system that then profits from

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Speaker 1: the multiple diseases that result from things like obesity is

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Speaker 1: kind of the perfect dystopian partnership. What do you think

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Speaker 1: about that first? And and do you think the FDA

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Speaker 1: has played a role in that. I don't personally think

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Speaker 1: that is the exact issue. I think it is an issue.

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Speaker 1: I think certainly food companies, like every other company in

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Speaker 1: this country, are there to make a profit. The problem

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Speaker 1: is we have no idea what a healthy diet looks

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Speaker 1: like because nutrition science is the worst science that we have,

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Speaker 1: and so we've got people out there hawking books, you know,

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Speaker 1: on diets, something say well, you gotta have a high

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Speaker 1: carb diet, and so you have to have a low

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Speaker 1: carb diet, high fat diet, low fat diet, on and

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Speaker 1: on and on. And the truth of the matter is

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Speaker 1: one we don't know, and to what we're beginning to

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Speaker 1: find out is that one diet probably isn't right for everyone.

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Speaker 1: Different people with different genetic backgrounds, different underlying health conditions

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Speaker 1: probably need different diets. So I think, in my mind

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Speaker 1: a bigger problem and this is why basically companies can

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Speaker 1: sell whatever they want. It's because we just don't know

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Speaker 1: enough yet because the science is so bad. Well that

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Speaker 1: that that's a good point. I think to pivot to

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Speaker 1: another aspect that you touch on in your book. You

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Speaker 1: believe that entrepreneurs are solving many problems that the FDA

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Speaker 1: can't or won't. Can you talk more about that. FDA

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Speaker 1: has recently announced they're going to start looking at technologies.

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Speaker 1: So the first thing that they're gonna do, and this

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Speaker 1: is gonna be tremendously helpful if we can get it done,

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Speaker 1: is using blockchain, the same thing that you use for cryptocurrency,

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Speaker 1: in order to start recalling things faster. For example, this

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Speaker 1: technology could in theory, reduce the time it takes to

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Speaker 1: trace the origin of a contaminated food upbreak from two

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Speaker 1: weeks into two seconds. So that does several things. One,

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Speaker 1: if you can trace sinks back very quickly, you can

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Speaker 1: find out what the root caused us in others, what

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Speaker 1: actually went wrong that caused this problem. More importantly, it

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Speaker 1: gets bad products off the market more quickly. And it

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Speaker 1: also doesn't basically indict everybody right yes, which sort of

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Speaker 1: leads to something that you've entered at already in this interview,

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Speaker 1: which is that the playing field is not necessarily level

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Speaker 1: between small companies and big companies. Can you talk more

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Speaker 1: about that? So there's a law on the regulatary flexibility

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Speaker 1: access we have to take into account. You know what

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Speaker 1: the impacts these things are on small producers, and if

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Speaker 1: we can to give them some kind of relief, And

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Speaker 1: given the fact that the benefits birth that great, I said, well,

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Speaker 1: at least let's examp some of these small firms and

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Speaker 1: make the requirements easier on them. We didn't do that.

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Speaker 1: Of course, all the large firms didn't want to give

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Speaker 1: small firms a break. But as they say, it's an

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Speaker 1: unlevel playing field. They have much more influence over FDA,

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Speaker 1: and this is true in any regulatory agency than the

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Speaker 1: small firms do. So the small firms get driven out

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Speaker 1: of business, and I think it's a shame that we

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Speaker 1: have two different laws that are supposed to protect small

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Speaker 1: firms and we're still not doing enough for them. One

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Speaker 1: of the other topics that you you touch on, and

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Speaker 1: that that I've encountered in other environments is the topic

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Speaker 1: of conflict of interest. One of the things that I

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Speaker 1: just have a hard time getting over is government employees

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Speaker 1: leaving the FDA and going to work for the corporations

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Speaker 1: that they're trying to regulate. And you give a very

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Speaker 1: poignant example of a person who wrote a regulation just

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Speaker 1: so that they could jump out and get a job

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Speaker 1: consulting on that same regulation to help corporations figure out

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Speaker 1: how to wend their way through it. Is that common.

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Speaker 1: It's hard for me to know. I don't have data

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Speaker 1: on how common is. I certainly saw it often enough.

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Speaker 1: The law allows it. What they do say is that

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Speaker 1: it has to be a number of years before you

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Speaker 1: can come back and lobby the f DAY for that industry.

404
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Speaker 1: But you can go out and work for them. You

405
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Speaker 1: can tell them how to comply, and you can make money.

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Speaker 1: I could be wrong, about this, But I think a

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Speaker 1: lot of people feel, you know what, I work in

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Speaker 1: a quote unquote low wage government job. I should be

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Speaker 1: allowed to go out and make money like everybody else.

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Speaker 1: I sort of served my country in this job, and

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Speaker 1: I have some sympathy for that. But again, like you say,

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Speaker 1: it seems to be something wrong if you can be

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Speaker 1: a part of writing a rule and then you know,

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Speaker 1: right it in such a way that you can go

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Speaker 1: out and profit from it. Yeah. I mean this is

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Speaker 1: a really hard question, so I don't expect an answer, honestly,

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Speaker 1: But how do you solve that problem? You know, it's

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Speaker 1: just a great question. I wish I did know, But

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Speaker 1: I'm pretty sure it's not the worst problem. F d A.

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Speaker 1: What's the worst problem? The fact that they're not solving

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Speaker 1: any problems, the fact that decades and decades go by,

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Speaker 1: uh there, their budget keeps going up, they get more people,

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Speaker 1: people believe in them, they believe that they're keeping us safe,

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Speaker 1: and that it just keeps going like that. And the

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Speaker 1: fact that you can go to Congress every single year

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Speaker 1: and say we've got to do something. One out of

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Speaker 1: six people in this country getting sick from food poisoning

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Speaker 1: every year for thirty or forty years you're saying the

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Speaker 1: same thing. Congress goes, oh my god, that's terrible, we

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Speaker 1: got to give you more money. Well, no, sooner or

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Speaker 1: later you gotta start saying, Okay, you gotta do something different. So,

432
00:26:31,400 --> 00:26:34,720
Speaker 1: just to be fair, are there any big winds that

433
00:26:34,800 --> 00:26:36,679
Speaker 1: you would point two times that the f d A

434
00:26:36,800 --> 00:26:41,040
Speaker 1: has gotten it really right? Oh? Absolutely, And first of all,

435
00:26:41,119 --> 00:26:43,480
Speaker 1: let me say, a lot of it is the system.

436
00:26:43,480 --> 00:26:45,200
Speaker 1: It's not the people. There are a lot of great

437
00:26:45,240 --> 00:26:48,719
Speaker 1: people that work for FDA. They're very smart, they're very dedicated,

438
00:26:48,760 --> 00:26:53,120
Speaker 1: they believe in it, but unfortunately they they they've run

439
00:26:53,119 --> 00:26:55,520
Speaker 1: out of ideas. But one thing I think where we

440
00:26:55,560 --> 00:26:59,240
Speaker 1: got it right was transfatty acids. This was a case

441
00:26:59,359 --> 00:27:03,040
Speaker 1: where an initially we were just going to ask firms

442
00:27:03,040 --> 00:27:05,800
Speaker 1: if they wanted to voluntarily label it. Trans fatty acids

443
00:27:05,840 --> 00:27:09,160
Speaker 1: are worse for you than than saturated fats, so that

444
00:27:09,240 --> 00:27:11,359
Speaker 1: was the bottom line. We really needed to do something,

445
00:27:11,960 --> 00:27:13,680
Speaker 1: so we kind of went round and round. There's a

446
00:27:13,680 --> 00:27:16,720
Speaker 1: long story about it, but we ended up with mandatory

447
00:27:16,800 --> 00:27:19,760
Speaker 1: labeling and companies sort of got the message and they

448
00:27:19,760 --> 00:27:23,320
Speaker 1: began pulling trans fatty acids because they're added to most foods,

449
00:27:23,520 --> 00:27:25,520
Speaker 1: so if they're added, that means you can easily take

450
00:27:25,520 --> 00:27:27,960
Speaker 1: them out as opposed to saturated fat, which is just

451
00:27:28,040 --> 00:27:30,960
Speaker 1: a part of the food. So they started take them

452
00:27:30,960 --> 00:27:35,119
Speaker 1: out and then eventually adding them has become illegal. I

453
00:27:35,160 --> 00:27:37,120
Speaker 1: think that's probably one of the best things that we did.

454
00:27:37,640 --> 00:27:40,400
Speaker 1: Is there anything that I haven't asked you about that

455
00:27:40,480 --> 00:27:43,600
Speaker 1: you think people should know about the f d A.

456
00:27:44,320 --> 00:27:47,080
Speaker 1: I do think right now with the Commissioner saying our

457
00:27:47,119 --> 00:27:49,960
Speaker 1: food safety system is broken with what has been happening

458
00:27:50,000 --> 00:27:52,560
Speaker 1: with infant formula, which f d A incidentally played a

459
00:27:52,680 --> 00:27:55,760
Speaker 1: huge role in why that happened. For forty years they've

460
00:27:55,760 --> 00:27:57,760
Speaker 1: been telling firms who want to come and start making

461
00:27:57,840 --> 00:28:01,360
Speaker 1: infant formulated, said no, they've kept it at six firms

462
00:28:02,440 --> 00:28:05,640
Speaker 1: new kidding. So they created essentially the monopoly that then

463
00:28:06,160 --> 00:28:09,720
Speaker 1: right hurt the hurt the whole countactly exactly. So when

464
00:28:09,760 --> 00:28:12,359
Speaker 1: you had one manufacturer drop out, of course there's a

465
00:28:12,440 --> 00:28:15,320
Speaker 1: huge problem. So with with these problems coming up, I

466
00:28:15,359 --> 00:28:17,560
Speaker 1: think the curtain has fallen down and we see what's

467
00:28:17,560 --> 00:28:20,439
Speaker 1: going on behind the curtain. Yeah, it couldn't have a

468
00:28:20,480 --> 00:28:22,920
Speaker 1: better time to start thinking about doing things in new

469
00:28:22,920 --> 00:28:25,879
Speaker 1: way and actually trying to solve problems than just appear

470
00:28:25,960 --> 00:28:28,520
Speaker 1: to be doing that something. So I'm hoping now is

471
00:28:28,560 --> 00:28:31,280
Speaker 1: the time. That's a nice note to wrap up on.

472
00:28:31,400 --> 00:28:34,520
Speaker 1: So let's just say that you're the FDA commissioner for

473
00:28:34,560 --> 00:28:38,000
Speaker 1: a day, or a month, or a year, for whatever

474
00:28:38,080 --> 00:28:42,280
Speaker 1: period of time is necessary to make real change. What

475
00:28:42,320 --> 00:28:46,760
Speaker 1: would you do to help the f d A achieve

476
00:28:47,080 --> 00:28:50,000
Speaker 1: its stated mission, which, as it says on the website,

477
00:28:50,000 --> 00:28:52,480
Speaker 1: it says as in the past, the FDA strives above

478
00:28:52,600 --> 00:28:55,920
Speaker 1: all else to safeguard the health and well being of

479
00:28:55,920 --> 00:28:59,000
Speaker 1: the American people. What's the one thing you would change

480
00:28:59,000 --> 00:29:02,800
Speaker 1: about the FDA to help them achieve that goal. I would,

481
00:29:02,960 --> 00:29:05,440
Speaker 1: I would retask them. I would say, look, we're not

482
00:29:05,480 --> 00:29:08,120
Speaker 1: going to pass all these regulations. Let's start looking at

483
00:29:08,120 --> 00:29:11,680
Speaker 1: these new technologies. If we think they're not completely safe,

484
00:29:11,680 --> 00:29:14,160
Speaker 1: that they need some sort of adjustment, let's focus on those,

485
00:29:14,480 --> 00:29:17,880
Speaker 1: let's promote them. I'll just give you quickly a list

486
00:29:17,920 --> 00:29:22,760
Speaker 1: of things. Precision fermentation, genetic engineering, three D printers are

487
00:29:22,760 --> 00:29:25,760
Speaker 1: coming along, consumer nutrition devices. They're going to have to

488
00:29:25,800 --> 00:29:29,560
Speaker 1: go through the medical device basically preapproval thing. We've got

489
00:29:29,560 --> 00:29:32,520
Speaker 1: to get those through faster. Those are gonna help consumers

490
00:29:32,600 --> 00:29:36,880
Speaker 1: eat better, nanopackaging, where we have smart packaging consumers when

491
00:29:36,880 --> 00:29:40,120
Speaker 1: their food is becoming spoiled. All of these things, I

492
00:29:40,120 --> 00:29:43,040
Speaker 1: would say, let's start looking there. That's the future. Those

493
00:29:43,080 --> 00:29:46,120
Speaker 1: are the solutions. Let's start looking at real solutions and

494
00:29:46,160 --> 00:29:50,080
Speaker 1: stop trying to pass these regulations. They were fine a

495
00:29:50,120 --> 00:29:52,520
Speaker 1: hundred years ago, they're not fine now, so I would

496
00:29:52,600 --> 00:29:58,080
Speaker 1: retask them. I love that, Okay, Richard. On this show,

497
00:29:58,400 --> 00:30:00,800
Speaker 1: we have a tool that we call the b S

498
00:30:00,920 --> 00:30:05,080
Speaker 1: scale that we used to measure the gap between word

499
00:30:05,120 --> 00:30:07,800
Speaker 1: and deed. And our scale goes from zero to one,

500
00:30:08,520 --> 00:30:12,880
Speaker 1: zero being the best zero bs and a hundred being

501
00:30:12,880 --> 00:30:16,760
Speaker 1: the worst total BS. So what score would you give

502
00:30:17,160 --> 00:30:20,040
Speaker 1: the f D A Well, mostly I'm qualified to talk

503
00:30:20,080 --> 00:30:22,240
Speaker 1: about the food's part the FDA, so I'll just focus

504
00:30:22,280 --> 00:30:26,280
Speaker 1: on them on that scale, because you know, they say

505
00:30:26,320 --> 00:30:29,440
Speaker 1: that they're protecting consumers. They say all these things, and

506
00:30:29,480 --> 00:30:31,400
Speaker 1: they're not doing it. I would give them about a

507
00:30:31,440 --> 00:30:35,840
Speaker 1: seventy five. So it's of what they do in foods

508
00:30:35,920 --> 00:30:41,400
Speaker 1: is bullshit. Okay, room for improvement, all right, Richard, thank

509
00:30:41,440 --> 00:30:43,120
Speaker 1: you so much for being here today. This was a

510
00:30:43,120 --> 00:30:45,080
Speaker 1: great conversation, and I also want to thank you for

511
00:30:45,120 --> 00:30:47,080
Speaker 1: writing this book and doing the work that you're doing

512
00:30:47,320 --> 00:30:49,960
Speaker 1: post your time at the FDA. It's incredibly important and

513
00:30:50,040 --> 00:30:51,880
Speaker 1: we thank you for it. Well, thank you again for

514
00:30:51,920 --> 00:30:56,560
Speaker 1: having me on. It's been great. Well, that's interesting, if

515
00:30:56,600 --> 00:31:01,720
Speaker 1: not totally disconcerting. Earlier in the episode, Lauren Adder posited

516
00:31:01,760 --> 00:31:04,280
Speaker 1: that the FDA had fallen short due to a lack

517
00:31:04,320 --> 00:31:09,719
Speaker 1: of resources, but Richard, a former FDA employee, says that

518
00:31:09,760 --> 00:31:14,560
Speaker 1: the organization floundered in spite of a consistently increasing budget.

519
00:31:15,320 --> 00:31:18,080
Speaker 1: If there was a harbinger of bullshit before, there now

520
00:31:18,120 --> 00:31:22,240
Speaker 1: seems to be a flashing neon arrow. But to be fair,

521
00:31:22,680 --> 00:31:27,880
Speaker 1: we've yet to explore the biggest inter agency. Buckle up, folks,

522
00:31:27,920 --> 00:31:31,480
Speaker 1: because next we're looking into the f d a's Center

523
00:31:31,560 --> 00:31:50,520
Speaker 1: of Drug Evaluation and Research. Right after this. Okay, folks,

524
00:31:51,080 --> 00:31:54,840
Speaker 1: it is my great pleasure to introduce Dr Gail Van

525
00:31:54,920 --> 00:31:58,480
Speaker 1: Norman to the show. Gail, welcome to Calling Bullshit. Well,

526
00:31:58,520 --> 00:32:01,640
Speaker 1: thank you, Ti, it's a pleasure to be here. Gail

527
00:32:01,760 --> 00:32:04,600
Speaker 1: is a clinician and professor at the University of Washington.

528
00:32:05,000 --> 00:32:08,880
Speaker 1: She writes and teaches about the medical research process, everything

529
00:32:08,960 --> 00:32:13,160
Speaker 1: from the FDA to commercialization to how animal testing works.

530
00:32:15,080 --> 00:32:18,520
Speaker 1: So the reason that we're doing this episode on calling

531
00:32:18,560 --> 00:32:21,120
Speaker 1: BS is that the f d A has come up

532
00:32:21,520 --> 00:32:24,280
Speaker 1: a couple of times on this show, and our research

533
00:32:24,400 --> 00:32:26,560
Speaker 1: left me with the impression that the f d A

534
00:32:26,840 --> 00:32:31,440
Speaker 1: sometimes gets things very right and sometimes it gets things

535
00:32:31,720 --> 00:32:34,560
Speaker 1: very wrong. Would you agree with that? I would. I

536
00:32:34,600 --> 00:32:39,040
Speaker 1: think the the FDA operates under constraints that are imperfect,

537
00:32:39,160 --> 00:32:43,000
Speaker 1: and even the best of organizations tasked with such a

538
00:32:43,040 --> 00:32:47,520
Speaker 1: complex mission are going to have misses and hits. Over All,

539
00:32:47,520 --> 00:32:50,760
Speaker 1: the FDA has had a number of spectacular hits and

540
00:32:51,040 --> 00:32:54,640
Speaker 1: pretty notable failures. Yeah, so let's let's get into some

541
00:32:54,680 --> 00:32:57,280
Speaker 1: of those, because I'd love to have you start out providing,

542
00:32:57,520 --> 00:32:59,920
Speaker 1: you know, an example or two of times when the

543
00:33:00,040 --> 00:33:02,840
Speaker 1: FDA has truly lived up to their mission and really

544
00:33:02,880 --> 00:33:05,960
Speaker 1: gotten it right. Okay, Well, let's start with the lidamide

545
00:33:05,960 --> 00:33:09,640
Speaker 1: because it's a sort of a classic historical example of

546
00:33:09,640 --> 00:33:12,320
Speaker 1: what can go right and wrong with medical research, as

547
00:33:12,320 --> 00:33:16,040
Speaker 1: well as what happens at the FDA. Phillidamide was an

548
00:33:16,080 --> 00:33:20,080
Speaker 1: anti nausea drug introduced in Germany in the nineteen fifties,

549
00:33:20,400 --> 00:33:23,520
Speaker 1: and it was considered one of the safest consumer drugs

550
00:33:23,560 --> 00:33:27,120
Speaker 1: ever to hit the market because it was so safe

551
00:33:27,760 --> 00:33:32,360
Speaker 1: practitioners really picked out its use in pregnancy because nausea

552
00:33:32,440 --> 00:33:34,840
Speaker 1: during pregnancy is not only a misery to women, it

553
00:33:34,880 --> 00:33:37,120
Speaker 1: can be dangerous to the health of the mother and

554
00:33:37,160 --> 00:33:40,000
Speaker 1: the fetus in utero, and so having something that controls

555
00:33:40,080 --> 00:33:43,360
Speaker 1: nausea and vomiting is very important. The drug had been

556
00:33:43,440 --> 00:33:47,080
Speaker 1: tested in animals prior to human tests that had been tested,

557
00:33:47,080 --> 00:33:50,720
Speaker 1: and I believe the number is something like fifty or

558
00:33:50,720 --> 00:33:53,720
Speaker 1: a hundred different species of animals, including rats and mice

559
00:33:53,800 --> 00:33:57,720
Speaker 1: and dogs and cats and armadillos and ferrets and rabbits.

560
00:33:58,120 --> 00:33:59,920
Speaker 1: It was considered such a safe drug that it was

561
00:34:00,040 --> 00:34:02,880
Speaker 1: not required that you have a prescription to use it. Uh.

562
00:34:02,920 --> 00:34:06,560
Speaker 1: The drug manufacturer gave it away free to its factory

563
00:34:06,560 --> 00:34:11,440
Speaker 1: workers pregnant factory workers to use during pregnancy. Wanting to

564
00:34:11,480 --> 00:34:14,880
Speaker 1: expand the market into the US, the manufacturer submitted the

565
00:34:14,960 --> 00:34:17,880
Speaker 1: drug for review with the f d A. The committee

566
00:34:17,920 --> 00:34:22,440
Speaker 1: reviewing Philidamie was headed by Francis Oldham Kelsey, who just

567
00:34:22,520 --> 00:34:25,719
Speaker 1: so happened to be the first woman to hold the position.

568
00:34:27,640 --> 00:34:29,799
Speaker 1: She later joked that they gave her what they thought

569
00:34:29,840 --> 00:34:32,000
Speaker 1: would be the easiest one they could possibly give and

570
00:34:32,040 --> 00:34:33,920
Speaker 1: whether they did that because she was a woman or

571
00:34:33,960 --> 00:34:37,200
Speaker 1: she was new. We'll just leave to speculation. Anyway, she

572
00:34:37,239 --> 00:34:40,080
Speaker 1: read the data and something about it didn't ring true

573
00:34:40,120 --> 00:34:42,160
Speaker 1: with her. She didn't like it, and she said, I'm

574
00:34:42,200 --> 00:34:44,440
Speaker 1: not going to approve this. I'm gonna stop you, and

575
00:34:44,480 --> 00:34:48,040
Speaker 1: I want to see a few more studies. And just

576
00:34:48,160 --> 00:34:51,480
Speaker 1: a few months later, on Christmas Day, in the first

577
00:34:51,480 --> 00:34:55,560
Speaker 1: baby was born in Germany without years, a little baby girl.

578
00:34:55,960 --> 00:34:59,279
Speaker 1: And that was followed by over ten thousand cases of

579
00:34:59,400 --> 00:35:03,440
Speaker 1: severely deformed infants that were born and probably twenty cases

580
00:35:03,440 --> 00:35:07,960
Speaker 1: of in utero deaths. And the US saw exactly seventeen

581
00:35:08,080 --> 00:35:14,480
Speaker 1: cases of thelidamid deformities, presumably in the children of mothers

582
00:35:14,520 --> 00:35:16,920
Speaker 1: who brought the drug in from out of country. We

583
00:35:16,920 --> 00:35:19,640
Speaker 1: were saved that plague because we never approved the drug

584
00:35:19,680 --> 00:35:23,440
Speaker 1: in the United States for that use. I mean that Actually,

585
00:35:23,480 --> 00:35:25,920
Speaker 1: I had a galvanic response to that story, like it

586
00:35:25,960 --> 00:35:27,680
Speaker 1: makes the hair on the back of my next stand

587
00:35:27,760 --> 00:35:29,719
Speaker 1: up to make me think how close we came to

588
00:35:29,760 --> 00:35:35,280
Speaker 1: a total unmitigated disaster. You know, yeah, it really is true.

589
00:35:35,840 --> 00:35:39,200
Speaker 1: And let's let's talk about COVID also, because that's fresh

590
00:35:39,239 --> 00:35:42,560
Speaker 1: in everyone's mind, and that's clearly a case where you know,

591
00:35:42,760 --> 00:35:46,880
Speaker 1: I mean it seemingly the normal process takes forever, and

592
00:35:46,920 --> 00:35:50,960
Speaker 1: it just it feels like COVID vaccines just magically appeared.

593
00:35:51,120 --> 00:35:54,560
Speaker 1: How did that happen? It was very incredible, right. Yeah.

594
00:35:55,080 --> 00:35:57,279
Speaker 1: I'm thinking to myself two and a half years ago

595
00:35:57,440 --> 00:36:01,920
Speaker 1: when COVID hit and I have in my distant medical background,

596
00:36:01,960 --> 00:36:05,360
Speaker 1: I have a background in immunology, and I remember people

597
00:36:05,400 --> 00:36:07,319
Speaker 1: coming and asking me, well, how long will it take

598
00:36:07,320 --> 00:36:09,480
Speaker 1: for us to have a vaccine? And the average time

599
00:36:09,520 --> 00:36:12,560
Speaker 1: to get a vaccine created for a new disease is

600
00:36:12,600 --> 00:36:17,480
Speaker 1: fifteen years, So it's it was like, so right away

601
00:36:17,480 --> 00:36:21,160
Speaker 1: what was happening was the the government was saying We'll

602
00:36:21,160 --> 00:36:23,319
Speaker 1: have a vaccine for you in a year, and I

603
00:36:23,400 --> 00:36:25,719
Speaker 1: was going, not, on your life, you won't. It's just

604
00:36:25,800 --> 00:36:30,120
Speaker 1: not trying to happen. No chance. But of course there

605
00:36:30,320 --> 00:36:36,800
Speaker 1: was a chance due to several important factors all occurring simultaneously. First,

606
00:36:37,080 --> 00:36:40,959
Speaker 1: the US government created a public private partnership offering ten

607
00:36:41,120 --> 00:36:45,359
Speaker 1: billion dollars to pharmaceutical companies to start immediately making and

608
00:36:45,400 --> 00:36:52,640
Speaker 1: testing vaccines. Second, the mRNA vaccine had become available. This

609
00:36:52,719 --> 00:36:55,520
Speaker 1: new technology created a way for the body to show

610
00:36:55,520 --> 00:36:59,920
Speaker 1: effecsimile of the virus to itself, making testing on humans

611
00:37:00,280 --> 00:37:04,880
Speaker 1: much easier. And finally, the Century Cures Act allowed for

612
00:37:05,000 --> 00:37:11,000
Speaker 1: emergency authorization and the quick release of the vaccines. All

613
00:37:11,040 --> 00:37:15,560
Speaker 1: those things came together. It's just amazing. Yeah, it is amazing.

614
00:37:16,600 --> 00:37:20,720
Speaker 1: So the litamide and covid vaccines y f d A truly,

615
00:37:21,040 --> 00:37:23,319
Speaker 1: and they do so many more things right as well.

616
00:37:23,360 --> 00:37:26,240
Speaker 1: Those are just a couple of examples. But let's let's

617
00:37:26,280 --> 00:37:29,719
Speaker 1: pivot to where they get it wrong. For for me,

618
00:37:30,200 --> 00:37:33,080
Speaker 1: because we did the research we did, Purdue Pharma comes

619
00:37:33,120 --> 00:37:38,720
Speaker 1: to mind and the OxyContin crisis. So the thing that

620
00:37:38,719 --> 00:37:41,839
Speaker 1: that shocked me about the Purdue situation and I did

621
00:37:41,840 --> 00:37:46,040
Speaker 1: not I did not understand this prior to doing this research.

622
00:37:46,200 --> 00:37:48,920
Speaker 1: But there are people at the FDA who have to

623
00:37:49,000 --> 00:37:53,000
Speaker 1: write the language that goes on warning labels on drugs,

624
00:37:53,520 --> 00:37:57,480
Speaker 1: and there are different kinds of warning labels. And the

625
00:37:57,560 --> 00:38:04,360
Speaker 1: big thing in in news world OxyContin was addictiveness. Any

626
00:38:04,440 --> 00:38:08,359
Speaker 1: opioid heretofore had been deemed to be addictive and had

627
00:38:08,400 --> 00:38:11,120
Speaker 1: to carry a label that said it was addictive and

628
00:38:11,280 --> 00:38:14,759
Speaker 1: would be prescribed in that same way. I e very sparingly,

629
00:38:15,760 --> 00:38:18,280
Speaker 1: and Purdue figured out a way to get the warning

630
00:38:18,360 --> 00:38:22,439
Speaker 1: label written in such a way as to avoid any

631
00:38:22,520 --> 00:38:27,480
Speaker 1: language of addiction, so that more doctors would be inclined

632
00:38:27,719 --> 00:38:32,440
Speaker 1: to write prescriptions for it. And my understanding of this

633
00:38:32,520 --> 00:38:35,320
Speaker 1: story is that the person who wrote the language actually

634
00:38:36,040 --> 00:38:39,040
Speaker 1: hold up in a hotel room with the executives from

635
00:38:39,040 --> 00:38:44,120
Speaker 1: Purdue and they all crafted that language together. And so

636
00:38:44,280 --> 00:38:49,120
Speaker 1: this gets to a larger issue obviously, which is sort

637
00:38:49,120 --> 00:38:54,080
Speaker 1: of the revolving door or the I would say, fraught

638
00:38:54,120 --> 00:39:00,400
Speaker 1: relationship between giant for profit industries and low paid government workers.

639
00:39:01,280 --> 00:39:05,640
Speaker 1: And further, to sort of add insult entry, once the

640
00:39:05,680 --> 00:39:09,560
Speaker 1: language had been crafted, once OxyContin was approved and being

641
00:39:09,640 --> 00:39:13,399
Speaker 1: sold across the world, that person left the f d

642
00:39:13,440 --> 00:39:17,040
Speaker 1: A and took a job at Purdue Pharma, you know,

643
00:39:17,160 --> 00:39:21,359
Speaker 1: kind of closing the circle as it were. And you know,

644
00:39:21,719 --> 00:39:26,640
Speaker 1: that story really disturbed me. It outraged me, honestly, and

645
00:39:26,800 --> 00:39:29,000
Speaker 1: I would love to hear your take on that and

646
00:39:29,239 --> 00:39:33,120
Speaker 1: how widespread a problem like that really is. I think

647
00:39:33,160 --> 00:39:36,200
Speaker 1: what you're getting at is a real problem in that

648
00:39:36,360 --> 00:39:40,600
Speaker 1: there is a variously porous interface between the kinds of

649
00:39:40,680 --> 00:39:44,480
Speaker 1: researchers who work within within the f d A and

650
00:39:44,560 --> 00:39:48,719
Speaker 1: those that work in commercial industry, and so people do

651
00:39:49,080 --> 00:39:53,160
Speaker 1: switch teams and that's perfectly legal right now, is it not?

652
00:39:53,520 --> 00:39:57,040
Speaker 1: Oh sure? I mean the current Commissioner of the FDA,

653
00:39:57,239 --> 00:40:00,640
Speaker 1: Robert Coliff, was an executive for or I can't remember

654
00:40:00,680 --> 00:40:04,279
Speaker 1: the name of the research company that's a subsidiary of

655
00:40:04,320 --> 00:40:06,920
Speaker 1: Alphabet anyway, he made two point seven million dollars a

656
00:40:07,040 --> 00:40:10,759
Speaker 1: year in salary and he used that And I'm not

657
00:40:10,760 --> 00:40:12,759
Speaker 1: criticizing him. I don't make it make it sound like

658
00:40:12,760 --> 00:40:15,919
Speaker 1: it was nefarious. That was actually a selling point for

659
00:40:16,040 --> 00:40:18,719
Speaker 1: his appointment as the Commissioner to the FDA because he

660
00:40:18,760 --> 00:40:21,960
Speaker 1: knew the ins and outs of commercial research companies. So

661
00:40:22,000 --> 00:40:24,799
Speaker 1: you can make an argument that it's helpful. And by

662
00:40:24,800 --> 00:40:27,920
Speaker 1: the way, his salary there right now is now three dollars,

663
00:40:27,920 --> 00:40:30,879
Speaker 1: which is considerably less. And he put in a lot

664
00:40:30,880 --> 00:40:35,000
Speaker 1: of agreements to say he would not participate in owning,

665
00:40:35,040 --> 00:40:38,359
Speaker 1: selling talking to you know, he self restricted to say,

666
00:40:38,560 --> 00:40:40,279
Speaker 1: I'm going to make sure you know that who I

667
00:40:40,320 --> 00:40:43,759
Speaker 1: work for, you know who my boss is. But other

668
00:40:43,800 --> 00:40:46,200
Speaker 1: people have not been quite so clear about it. And

669
00:40:46,280 --> 00:40:49,680
Speaker 1: so you have somebody who works on an FDA committee

670
00:40:49,840 --> 00:40:52,920
Speaker 1: and they have a drug presented to them, and the

671
00:40:52,960 --> 00:40:55,799
Speaker 1: people who are presenting the drug whisper in their ears Wow,

672
00:40:55,840 --> 00:40:58,879
Speaker 1: we really think your help has been really valuable, and

673
00:40:59,040 --> 00:41:01,239
Speaker 1: we'd like to get think about coming on as a

674
00:41:01,360 --> 00:41:04,520
Speaker 1: researcher or a head of marketing in our company. And

675
00:41:04,560 --> 00:41:07,040
Speaker 1: they offer you a two and a half million dollar raise,

676
00:41:07,480 --> 00:41:10,080
Speaker 1: it can be a little hard to turn it turned down.

677
00:41:11,960 --> 00:41:15,560
Speaker 1: And so there are connections which between the FDA and

678
00:41:15,719 --> 00:41:19,880
Speaker 1: the commercial world, which if properly aligned, are helpful because

679
00:41:19,880 --> 00:41:22,040
Speaker 1: it can give the FDA insights as to what the

680
00:41:22,040 --> 00:41:25,239
Speaker 1: company is doing, but if they're not properly aligned, can

681
00:41:25,320 --> 00:41:27,799
Speaker 1: lead to conflicts of interest into the detriment of the

682
00:41:27,840 --> 00:41:30,239
Speaker 1: safety and health of the American public. Right. So, the

683
00:41:30,280 --> 00:41:32,920
Speaker 1: FDA is a government organization with a mission to protect

684
00:41:33,000 --> 00:41:36,440
Speaker 1: us all from the effects, intended or not of private

685
00:41:36,600 --> 00:41:41,040
Speaker 1: for profit interests. So, so let's talk a little bit

686
00:41:41,080 --> 00:41:48,919
Speaker 1: about money. How does how does the FDA receive its funding? Well,

687
00:41:48,960 --> 00:41:54,000
Speaker 1: the FDA used to be back in the nineteen twenties,

688
00:41:54,080 --> 00:41:56,520
Speaker 1: it was all government funded. It just came out of

689
00:41:56,520 --> 00:41:59,960
Speaker 1: the General Treasury Fund for the FDA. Now, about forty

690
00:42:00,080 --> 00:42:03,600
Speaker 1: five percent of the FDA's funds come from something called

691
00:42:03,719 --> 00:42:06,680
Speaker 1: user fees and application fees that are paid by the

692
00:42:06,760 --> 00:42:10,680
Speaker 1: drug companies to get their drugs reviewed. When that was

693
00:42:10,760 --> 00:42:13,600
Speaker 1: first proposed, there was a lot of concern that this

694
00:42:13,640 --> 00:42:17,120
Speaker 1: would create a conflict of interest for the FDA because

695
00:42:17,200 --> 00:42:18,759
Speaker 1: a lot of their funding would come from the very

696
00:42:18,800 --> 00:42:23,200
Speaker 1: people they're trying to regulate. But it became so popular

697
00:42:23,320 --> 00:42:26,560
Speaker 1: because those user fees were enacted because the FDA was

698
00:42:26,640 --> 00:42:32,120
Speaker 1: woefully short staffed. Congress enacted this as a way specifically

699
00:42:32,160 --> 00:42:34,200
Speaker 1: for the FDA to hire the people that needed to

700
00:42:34,239 --> 00:42:37,560
Speaker 1: do the work, and it led to a big reduction

701
00:42:37,880 --> 00:42:41,239
Speaker 1: in through put times and it accomplished exactly what was

702
00:42:41,280 --> 00:42:43,480
Speaker 1: supposed to do. So it's still popular to this day.

703
00:42:43,880 --> 00:42:45,440
Speaker 1: And how much do you think the f d A

704
00:42:45,840 --> 00:42:52,160
Speaker 1: is affected by lobbying, either by big drug companies lobbying

705
00:42:52,480 --> 00:42:56,600
Speaker 1: on the health to change laws and regulations, or patient

706
00:42:56,640 --> 00:43:01,359
Speaker 1: advocacy groups lobbying to influence the way the organization is

707
00:43:02,120 --> 00:43:07,719
Speaker 1: is funded or regulated itself. Well, both affect the f

708
00:43:07,840 --> 00:43:10,400
Speaker 1: d A. I mean, it's not immune to them. The

709
00:43:10,480 --> 00:43:15,640
Speaker 1: FDA acts is funded, as I mentioned, from congressional funding,

710
00:43:16,320 --> 00:43:21,880
Speaker 1: and Congress is affected very heavily by patient advocacy. You

711
00:43:21,960 --> 00:43:25,760
Speaker 1: get patient advocacy groups getting Congress to write both good

712
00:43:25,840 --> 00:43:29,040
Speaker 1: and cockamami laws all the time. With regard to health

713
00:43:29,600 --> 00:43:32,080
Speaker 1: and so the f d A is not immune from

714
00:43:32,080 --> 00:43:36,239
Speaker 1: those effects. The other thing I would say that there's

715
00:43:36,280 --> 00:43:39,800
Speaker 1: no it's hard to say that there's a direct effect,

716
00:43:39,920 --> 00:43:43,439
Speaker 1: like you know, Glaxo smith Klein plays their two million

717
00:43:43,480 --> 00:43:46,040
Speaker 1: dollar drug fee and that makes the FDA prove the drug.

718
00:43:46,760 --> 00:43:51,759
Speaker 1: That doesn't happen. But the other kind of effect is

719
00:43:51,800 --> 00:43:55,480
Speaker 1: hard to regulate against. The individual who sits in an

720
00:43:55,520 --> 00:44:01,600
Speaker 1: influential part of a committee who then is favorably impressed

721
00:44:01,600 --> 00:44:04,560
Speaker 1: by a drug company about their drug in various ways

722
00:44:05,200 --> 00:44:09,600
Speaker 1: and advocates for it. Those do happen, and individuals that

723
00:44:09,640 --> 00:44:13,960
Speaker 1: sit on these committees can make big differences in what

724
00:44:14,160 --> 00:44:18,480
Speaker 1: the FDA decides to do. One of the things that

725
00:44:18,760 --> 00:44:21,320
Speaker 1: is just true is that our health care system is

726
00:44:21,400 --> 00:44:26,560
Speaker 1: run largely as a for profit enterprise. And is that

727
00:44:26,719 --> 00:44:32,480
Speaker 1: part of the problem here, oh sure? Or is that

728
00:44:32,520 --> 00:44:35,319
Speaker 1: the whole problem here? That that might even be the

729
00:44:35,320 --> 00:44:38,040
Speaker 1: whole problem for all we know. I mean, I suppose

730
00:44:38,120 --> 00:44:42,200
Speaker 1: there are good aspects commercialization, because it does, in an

731
00:44:42,239 --> 00:44:48,840
Speaker 1: ideal world, promote competition and innovation, but it also promotes

732
00:44:48,920 --> 00:44:53,080
Speaker 1: manipulation and profit taking, and neither of those serve patients

733
00:44:53,120 --> 00:44:56,080
Speaker 1: at all. They serve the companies that make the drugs,

734
00:44:56,400 --> 00:44:58,719
Speaker 1: and they're talking about well, that's right. I mean we're

735
00:44:58,719 --> 00:45:02,839
Speaker 1: not just talking about the company making a profit. We're

736
00:45:02,880 --> 00:45:07,880
Speaker 1: talking about unimaginable amounts of money. We're talking about a

737
00:45:07,960 --> 00:45:13,480
Speaker 1: drug generating a hundred billion dollars in profits, a hundred

738
00:45:13,719 --> 00:45:18,319
Speaker 1: billion dollars. So this is money that will buy anybody's soul, right,

739
00:45:19,040 --> 00:45:22,560
Speaker 1: maybe even mine? I don't think so, but you never know. Well,

740
00:45:22,760 --> 00:45:27,000
Speaker 1: and know, like, it's an interesting question to ask yourself, right,

741
00:45:27,120 --> 00:45:30,120
Speaker 1: is like what's my number? But in the current system,

742
00:45:30,480 --> 00:45:33,919
Speaker 1: the consequences for breaking the law often take the form

743
00:45:34,000 --> 00:45:39,319
Speaker 1: of fines. But with profits of that size, you know,

744
00:45:39,320 --> 00:45:41,200
Speaker 1: would it be fair to say the fines are just

745
00:45:41,239 --> 00:45:45,040
Speaker 1: a cost of doing business? Oh? Absolutely, it's it's amazing.

746
00:45:45,080 --> 00:45:47,040
Speaker 1: I mean, what you see in the media, what the

747
00:45:47,040 --> 00:45:50,480
Speaker 1: American public sees is the sacklers paid what was it

748
00:45:52,719 --> 00:45:58,120
Speaker 1: billion dollars? Well, weighed against what did they make. Even

749
00:45:58,160 --> 00:46:02,200
Speaker 1: if it's a hundred over a hundred billion, it's less

750
00:46:02,200 --> 00:46:05,719
Speaker 1: than of their whole profit margin. And remember it's not

751
00:46:05,800 --> 00:46:08,200
Speaker 1: just the profit, it's not just the actual dollars that

752
00:46:08,280 --> 00:46:11,279
Speaker 1: go in the bank. It's how much their stock is worth. Right,

753
00:46:11,719 --> 00:46:14,520
Speaker 1: So if you're making a hundred billion dollars in profits,

754
00:46:14,520 --> 00:46:18,680
Speaker 1: your stock becomes worth a huge amount more. And these

755
00:46:18,719 --> 00:46:22,880
Speaker 1: companies are run by individuals who have heavy stock interests,

756
00:46:23,400 --> 00:46:26,000
Speaker 1: who may have individual conflicts of interest with doing the

757
00:46:26,120 --> 00:46:30,000
Speaker 1: right thing, and more and more, we're talking about dollar

758
00:46:30,080 --> 00:46:34,799
Speaker 1: amounts that seem insurmountable in their ability to bribe and

759
00:46:34,880 --> 00:46:38,080
Speaker 1: attract people into behaviors that we would hope we wouldn't

760
00:46:38,080 --> 00:46:41,560
Speaker 1: see in this industry. Right And and you know, just

761
00:46:41,600 --> 00:46:45,319
Speaker 1: to contrast that, to make this really clear, how much

762
00:46:45,440 --> 00:46:49,919
Speaker 1: money would a typical f D A employee take home,

763
00:46:50,160 --> 00:46:53,160
Speaker 1: if there is such a thing, And how much can

764
00:46:53,200 --> 00:46:59,359
Speaker 1: we contrast that with an average pharma executive even just roughly? Uh? Well,

765
00:46:59,360 --> 00:47:04,480
Speaker 1: I I the farmer executives take home millions of dollars.

766
00:47:04,520 --> 00:47:07,720
Speaker 1: The average FDA salaries a hundred and ten thousand dollars

767
00:47:07,719 --> 00:47:11,839
Speaker 1: a year, and their top executive makes three dollars a year.

768
00:47:11,880 --> 00:47:16,960
Speaker 1: So it's considerably less than anything the commercial environment could offer, right. Yeah,

769
00:47:17,000 --> 00:47:20,520
Speaker 1: And it just seems like there's a massive incentive for

770
00:47:20,560 --> 00:47:22,960
Speaker 1: these big companies to try to figure out how to

771
00:47:23,000 --> 00:47:27,080
Speaker 1: gain the system in one way or another. Well, I

772
00:47:27,120 --> 00:47:30,640
Speaker 1: think it's not just there's this incentive. There's virtually no

773
00:47:30,880 --> 00:47:33,840
Speaker 1: disincentive to do it, because if you're that rich, you

774
00:47:33,880 --> 00:47:38,440
Speaker 1: can just pay the fine and move on, doesn't doesn't matter.

775
00:47:38,560 --> 00:47:41,600
Speaker 1: You actually factor that into the cost of developing the drug,

776
00:47:41,760 --> 00:47:44,359
Speaker 1: the cost of putting the drug out there. Yeah, well

777
00:47:44,360 --> 00:47:47,600
Speaker 1: that's terrifying. So, Gail, another way to look at our

778
00:47:47,640 --> 00:47:52,880
Speaker 1: show is fundamentally it's about trust, and it's just incredibly

779
00:47:52,920 --> 00:47:56,160
Speaker 1: important that we trust institutions like the f d A

780
00:47:56,239 --> 00:48:00,000
Speaker 1: literally lives around the line. And honestly, I can understand

781
00:48:00,040 --> 00:48:03,200
Speaker 1: in someone who has lost trust in politicians today or

782
00:48:03,239 --> 00:48:05,840
Speaker 1: in big pharma, or even in the f d A.

783
00:48:06,760 --> 00:48:10,839
Speaker 1: You know, this is the same institution that approved oxy.

784
00:48:10,920 --> 00:48:14,200
Speaker 1: So what are some things that you think the FDA

785
00:48:14,320 --> 00:48:18,960
Speaker 1: should do to try to rebuild trust with people. I think,

786
00:48:19,160 --> 00:48:22,520
Speaker 1: first of all, we need to start with Congress and say,

787
00:48:22,640 --> 00:48:26,120
Speaker 1: who do we have in Congress sitting on the committees

788
00:48:26,200 --> 00:48:29,880
Speaker 1: that give the FDA it's marching orders. Frankly, I can't.

789
00:48:30,840 --> 00:48:32,800
Speaker 1: I can't tell you who those people are. I should

790
00:48:32,800 --> 00:48:35,200
Speaker 1: be able to, but I can't right now, and do

791
00:48:35,239 --> 00:48:39,080
Speaker 1: I trust them, particularly when I well know that many

792
00:48:39,160 --> 00:48:42,839
Speaker 1: of our congressional representatives are, for lack of a better

793
00:48:42,880 --> 00:48:47,520
Speaker 1: word ignorance of science and how it works and don't

794
00:48:47,560 --> 00:48:51,400
Speaker 1: care to learn it, and the hander to sort of

795
00:48:51,440 --> 00:48:54,759
Speaker 1: the conspiracy theorists who want to think that we're all

796
00:48:54,760 --> 00:48:57,560
Speaker 1: out to get them. So I think we need to

797
00:48:57,600 --> 00:49:00,160
Speaker 1: look at that and ask should there be special or

798
00:49:00,239 --> 00:49:04,640
Speaker 1: qualifications for people who determine how this agency works. I

799
00:49:04,680 --> 00:49:07,880
Speaker 1: think overall the agency does a remarkable job given the

800
00:49:07,880 --> 00:49:11,160
Speaker 1: mission that it has and the number of opportunities for

801
00:49:11,239 --> 00:49:16,640
Speaker 1: failure that it has, how relatively few it really has experienced.

802
00:49:17,400 --> 00:49:19,239
Speaker 1: I think we need to look at how we can

803
00:49:19,280 --> 00:49:22,040
Speaker 1: reduce conflicts of interest that we've talked about within the

804
00:49:22,080 --> 00:49:25,280
Speaker 1: agency so that we don't have people who are pretending

805
00:49:25,320 --> 00:49:27,880
Speaker 1: to serve the FDA but are really serving a commercial

806
00:49:27,920 --> 00:49:31,360
Speaker 1: interest or serving themselves so that they can position themselves

807
00:49:31,400 --> 00:49:35,160
Speaker 1: for for a well paying job with the commercial companies.

808
00:49:35,200 --> 00:49:37,360
Speaker 1: I think that would be helpful. And I think we

809
00:49:37,400 --> 00:49:41,680
Speaker 1: need to have real penalties for pharmaceutical companies that openly

810
00:49:42,520 --> 00:49:45,439
Speaker 1: commit criminal acts. This is in the criminal Code now

811
00:49:46,440 --> 00:49:50,880
Speaker 1: produted things that were criminal, and that perhaps money is

812
00:49:50,920 --> 00:49:53,480
Speaker 1: not the price those people should be paying that people

813
00:49:54,200 --> 00:49:58,040
Speaker 1: people there should be real prison time assigned when those

814
00:49:58,040 --> 00:50:02,040
Speaker 1: sorts of things happen because as a CEO who knows

815
00:50:02,200 --> 00:50:04,480
Speaker 1: that their signature on a piece of paper might put

816
00:50:04,520 --> 00:50:07,240
Speaker 1: them in jail one day, may think twice before signing

817
00:50:07,239 --> 00:50:12,240
Speaker 1: it and may have better oversight. Yeah, okay, alright, Gail,

818
00:50:12,560 --> 00:50:16,080
Speaker 1: this is really my last question on this show. We

819
00:50:16,200 --> 00:50:20,480
Speaker 1: have a tool called the b S scale, and the

820
00:50:20,520 --> 00:50:24,480
Speaker 1: b S scale goes from zero to one, zero being

821
00:50:24,520 --> 00:50:29,120
Speaker 1: the best score meaning zero bs one being the worst

822
00:50:29,400 --> 00:50:34,040
Speaker 1: total bs. So on that scale, what score would you

823
00:50:34,160 --> 00:50:38,280
Speaker 1: give the f d A in achieving its stated mission?

824
00:50:39,360 --> 00:50:41,759
Speaker 1: I would give it a really good score. I think

825
00:50:41,800 --> 00:50:45,600
Speaker 1: that to do it's the complicated job it does, to

826
00:50:45,719 --> 00:50:48,439
Speaker 1: do it with the high degree of success, and it's

827
00:50:48,520 --> 00:50:52,680
Speaker 1: had in protecting the American public for nearly two hundred

828
00:50:52,760 --> 00:50:55,920
Speaker 1: years now. I think that they deserve a score of

829
00:50:57,080 --> 00:51:01,279
Speaker 1: and that they've done really, really well. Gail, I want

830
00:51:01,280 --> 00:51:04,040
Speaker 1: to thank you for being with us today. Thanks for

831
00:51:04,400 --> 00:51:07,560
Speaker 1: calling bullshit well, thank you for having me. It's been fun.

832
00:51:07,600 --> 00:51:11,359
Speaker 1: It really has been folks. It is time to make

833
00:51:11,360 --> 00:51:14,799
Speaker 1: the call. The f d A is a complicated institution

834
00:51:14,960 --> 00:51:19,319
Speaker 1: with huge responsibilities. We couldn't possibly cover the entirety of

835
00:51:19,360 --> 00:51:22,239
Speaker 1: what they do in a single episode, but with the

836
00:51:22,239 --> 00:51:24,560
Speaker 1: help of our three experts, we're still able to get

837
00:51:24,680 --> 00:51:29,360
Speaker 1: enough insight to answer the fundamental question, does the f

838
00:51:29,480 --> 00:51:33,680
Speaker 1: d A strive above all else to safeguard the health

839
00:51:33,920 --> 00:51:39,480
Speaker 1: of the American people. Although they've had some notable successes,

840
00:51:40,080 --> 00:51:45,560
Speaker 1: we're calling bullshit on the f d A, But as always,

841
00:51:45,760 --> 00:51:48,319
Speaker 1: we're not here to just curse the darkness. When we

842
00:51:48,440 --> 00:51:51,520
Speaker 1: come back, we'll speak with an expert in f d

843
00:51:51,680 --> 00:51:54,399
Speaker 1: A conflicts of interest to see if we can light

844
00:51:54,440 --> 00:51:57,760
Speaker 1: a few candles in the halls of this bureaucratic beheemoth.

845
00:52:14,840 --> 00:52:18,280
Speaker 1: My name is Genevieve Cantor. I am an assistant professor

846
00:52:18,520 --> 00:52:22,000
Speaker 1: at the Proman School of Medicine at the University of Pennsylvania.

847
00:52:22,160 --> 00:52:27,040
Speaker 1: I'm trained as an economist and I study regulation of

848
00:52:27,120 --> 00:52:31,440
Speaker 1: biomedical technologies, the f d A, and conflicts of interest.

849
00:52:32,040 --> 00:52:34,600
Speaker 1: Thank you for being here and welcome to calling bullshit.

850
00:52:35,520 --> 00:52:38,760
Speaker 1: Thanks happy to be here. What we're here to do

851
00:52:39,120 --> 00:52:42,759
Speaker 1: is talk about ideas for helping the f d A

852
00:52:42,920 --> 00:52:48,360
Speaker 1: better live their purpose. And before we get into those ideas,

853
00:52:48,680 --> 00:52:50,640
Speaker 1: I don't do this in every show, but but I

854
00:52:50,680 --> 00:52:54,640
Speaker 1: wanted to actually say something to our listeners because I've

855
00:52:54,680 --> 00:52:58,160
Speaker 1: been feeling some of this stuff myself as I prepped

856
00:52:58,160 --> 00:53:02,080
Speaker 1: for this episode. It's really easy, and I would say

857
00:53:02,080 --> 00:53:06,000
Speaker 1: even understandable, when faced with a problem as complex as

858
00:53:06,040 --> 00:53:08,799
Speaker 1: the FDA to basically just shrug and give up. And

859
00:53:08,840 --> 00:53:12,200
Speaker 1: it's it's easy to just declare that the problem is

860
00:53:12,239 --> 00:53:15,719
Speaker 1: impossible and to kind of move on. And I want

861
00:53:15,719 --> 00:53:18,720
Speaker 1: to ask our listeners to suspend their disbelief for this section,

862
00:53:18,840 --> 00:53:22,000
Speaker 1: because we really do want to explore actions that the

863
00:53:22,080 --> 00:53:25,320
Speaker 1: FDA or the executive branch to whom the FDA reports

864
00:53:25,360 --> 00:53:29,560
Speaker 1: could actually enact to help the f d A build

865
00:53:29,840 --> 00:53:33,720
Speaker 1: better trust with people and really deliver on the promise

866
00:53:33,760 --> 00:53:36,880
Speaker 1: of keeping all of us safer. It's such an important purpose,

867
00:53:37,640 --> 00:53:40,359
Speaker 1: and I really believe we need to take an optimistic

868
00:53:40,400 --> 00:53:45,880
Speaker 1: point of view here because giving up on it is unthinkable. Sorry,

869
00:53:45,920 --> 00:53:48,759
Speaker 1: I had to get that off my chest initially. So

870
00:53:48,880 --> 00:53:51,960
Speaker 1: let's get into some ideas. Genevieve, I'm gonna ask you

871
00:53:52,040 --> 00:53:55,839
Speaker 1: to go first. In two minutes, can you tell us

872
00:53:55,920 --> 00:53:59,640
Speaker 1: the one thing that you would do to change the

873
00:53:59,719 --> 00:54:04,600
Speaker 1: f So, if I were emperor of the United States,

874
00:54:04,840 --> 00:54:08,000
Speaker 1: the one thing I would do is to replace our

875
00:54:08,040 --> 00:54:11,239
Speaker 1: current approval process with a system where the firms are

876
00:54:11,320 --> 00:54:14,560
Speaker 1: given conditional approval of their products and they have to

877
00:54:14,600 --> 00:54:18,880
Speaker 1: seek renewal of approval every say, ten years. So in

878
00:54:18,920 --> 00:54:22,200
Speaker 1: the current system, a firm applies for approval of a

879
00:54:22,280 --> 00:54:25,759
Speaker 1: product and receives that approval until basically the end of

880
00:54:25,800 --> 00:54:28,560
Speaker 1: time or the sun burns itself out or something. So

881
00:54:29,040 --> 00:54:32,600
Speaker 1: with this ten year sort of renewable approval, you could

882
00:54:32,600 --> 00:54:36,000
Speaker 1: incentivize the monitoring of how well drugs are working, because

883
00:54:36,000 --> 00:54:38,840
Speaker 1: that will be required to get your renewal for the approval.

884
00:54:39,200 --> 00:54:42,440
Speaker 1: You incentivize the monitoring of how safe drugs are because

885
00:54:42,480 --> 00:54:46,480
Speaker 1: again that's part of the renewal process that will allow

886
00:54:46,600 --> 00:54:49,040
Speaker 1: us the government to pull drugs off the market that

887
00:54:49,160 --> 00:54:51,239
Speaker 1: turn out to be not effective or that turned out

888
00:54:51,239 --> 00:54:53,719
Speaker 1: to be unsafe, because sometimes you don't see a lot

889
00:54:53,719 --> 00:54:56,799
Speaker 1: of safety events in the small clinical trial populations and

890
00:54:56,840 --> 00:55:00,560
Speaker 1: you only see them in the broader population. I love

891
00:55:00,640 --> 00:55:05,160
Speaker 1: that idea. That is an incredibly smart idea. Not surprisingly,

892
00:55:05,560 --> 00:55:09,440
Speaker 1: you are the experts, so well done. I think that's

893
00:55:09,440 --> 00:55:12,399
Speaker 1: a fantastic idea. Will we will return to that, I'm

894
00:55:12,400 --> 00:55:15,520
Speaker 1: sure throughout the conversation. So here's my idea. The f

895
00:55:15,680 --> 00:55:19,719
Speaker 1: d A is much more important to all of us

896
00:55:19,880 --> 00:55:23,240
Speaker 1: than is currently reflected in the salaries of the people

897
00:55:23,239 --> 00:55:27,080
Speaker 1: who work there. Their job is literally to to save lives,

898
00:55:27,080 --> 00:55:31,240
Speaker 1: to protect us from harm. But there's a pretty massive

899
00:55:31,320 --> 00:55:33,920
Speaker 1: salary gap between the average f d A worker in

900
00:55:33,960 --> 00:55:38,680
Speaker 1: the average pharmat exact or food company exact, which has

901
00:55:38,719 --> 00:55:42,400
Speaker 1: resulted in this revolving door where regulators from the FDA

902
00:55:42,640 --> 00:55:46,680
Speaker 1: moved to higher paying jobs at food and drug companies.

903
00:55:47,520 --> 00:55:50,920
Speaker 1: And I think that the knowledge that that reward is

904
00:55:50,960 --> 00:55:54,439
Speaker 1: there waiting for them if they play ball while they're

905
00:55:54,440 --> 00:55:56,880
Speaker 1: at the f d A has the effect of creating

906
00:55:56,920 --> 00:56:00,279
Speaker 1: huge conflicts of interest. And so my idea is to

907
00:56:00,480 --> 00:56:05,680
Speaker 1: change the FDA through compensation reform, pay salaries competitive with

908
00:56:05,719 --> 00:56:08,839
Speaker 1: the private sector, because right now the FDA is kind

909
00:56:08,840 --> 00:56:13,040
Speaker 1: of a drab government bureaucracy and it attracts people who

910
00:56:13,120 --> 00:56:16,719
Speaker 1: are up for working in that kind of job. Closing

911
00:56:16,760 --> 00:56:20,000
Speaker 1: the salary gap would begin to level the playing field.

912
00:56:20,160 --> 00:56:23,040
Speaker 1: When you know you pay people more money, you attract

913
00:56:23,120 --> 00:56:27,040
Speaker 1: better people, and their job is so incredibly important that

914
00:56:27,040 --> 00:56:30,960
Speaker 1: that would be better for all of us. So salary

915
00:56:31,040 --> 00:56:33,320
Speaker 1: reform is the idea I want to put on the table.

916
00:56:33,360 --> 00:56:35,719
Speaker 1: But let's some we can we can get back to that.

917
00:56:35,760 --> 00:56:37,880
Speaker 1: I want to I want to talk more about your idea,

918
00:56:37,960 --> 00:56:42,200
Speaker 1: because I think it's so smart because when things and

919
00:56:42,200 --> 00:56:44,520
Speaker 1: and a lot goes right at the FDA, right, but

920
00:56:44,520 --> 00:56:48,560
Speaker 1: but when things go wrong, it's not often on day

921
00:56:48,600 --> 00:56:51,800
Speaker 1: one you don't know that a problem is a problem

922
00:56:51,960 --> 00:56:54,520
Speaker 1: right out of the gate. And yet once something is approved,

923
00:56:54,560 --> 00:56:57,200
Speaker 1: it's been released into the wild and you almost can't

924
00:56:57,280 --> 00:57:00,400
Speaker 1: get it back in the current system. And so that

925
00:57:00,480 --> 00:57:04,640
Speaker 1: I think that would you know, really increase people's safety.

926
00:57:04,719 --> 00:57:08,000
Speaker 1: What barriers do you think we would encounter if we

927
00:57:08,080 --> 00:57:11,280
Speaker 1: decided to try to actually enact that today? Who would

928
00:57:11,320 --> 00:57:14,640
Speaker 1: have an issue with that idea? Probably the same parties

929
00:57:14,680 --> 00:57:17,760
Speaker 1: that have blocked a lot of reforms in this space,

930
00:57:17,920 --> 00:57:21,520
Speaker 1: the pharmaceutical companies. I suspect that some of the arguments

931
00:57:21,560 --> 00:57:24,400
Speaker 1: that would be presented might be that it would be

932
00:57:24,880 --> 00:57:27,680
Speaker 1: even more costly and time consuming for firms than the

933
00:57:27,680 --> 00:57:33,840
Speaker 1: existing approval processes. Uh IN might delay access to some products,

934
00:57:34,200 --> 00:57:38,240
Speaker 1: But overall, broadly speaking, it's not politically feasible because the

935
00:57:38,360 --> 00:57:43,720
Speaker 1: drug companies would intensely oppose this kind of conditional approval.

936
00:57:44,600 --> 00:57:47,760
Speaker 1: And when they oppose that kind of thing, how does

937
00:57:47,880 --> 00:57:52,720
Speaker 1: what form does that opposition take? So every five years

938
00:57:52,920 --> 00:57:57,080
Speaker 1: there is legislation related to authorizing the budget for the

939
00:57:57,200 --> 00:58:00,280
Speaker 1: f D a um. In fact, there's actually currently the

940
00:58:00,280 --> 00:58:03,600
Speaker 1: re authorization happening this year and we expect to see

941
00:58:03,600 --> 00:58:07,360
Speaker 1: it past at the end of this summer actually, And

942
00:58:07,440 --> 00:58:11,520
Speaker 1: so usually it's through you know, lobbying legislators as to

943
00:58:12,600 --> 00:58:17,120
Speaker 1: the features that might go into this reauthorization package. So if,

944
00:58:17,400 --> 00:58:19,560
Speaker 1: for example, if it were to be introduced in one

945
00:58:19,560 --> 00:58:23,840
Speaker 1: of these five year reauthorization bill's armor as well as

946
00:58:23,880 --> 00:58:29,840
Speaker 1: individual pharmaceutical lobbyists would oppose the inclusion of such a conditionality,

947
00:58:30,840 --> 00:58:34,160
Speaker 1: and the lobbyists are there to threaten by removing financial

948
00:58:34,240 --> 00:58:38,720
Speaker 1: support from Congress. That's right through you know, campaign contributions.

949
00:58:39,880 --> 00:58:43,440
Speaker 1: M hmm. Yeah. That sort of leads us to a

950
00:58:43,520 --> 00:58:46,600
Speaker 1: discussion around conflict of interest in general. So so I

951
00:58:46,720 --> 00:58:49,000
Speaker 1: want to I want to go there, But before we

952
00:58:49,200 --> 00:58:52,720
Speaker 1: go there more deeply, what do you think of the

953
00:58:52,800 --> 00:58:55,200
Speaker 1: idea that I put on on the table, This idea

954
00:58:55,240 --> 00:58:58,120
Speaker 1: of like leveling the playing field from a salary standpoint,

955
00:58:58,160 --> 00:59:00,480
Speaker 1: Does that make any sense? I'd like it, And I

956
00:59:00,560 --> 00:59:05,040
Speaker 1: think you've tackled head on one of the issues with

957
00:59:05,240 --> 00:59:08,720
Speaker 1: the approval process at the FDA, which is they do

958
00:59:08,920 --> 00:59:13,080
Speaker 1: lose a lot of very good people because the pharmaceutical

959
00:59:13,160 --> 00:59:17,560
Speaker 1: companies are able to entice government workers who have a

960
00:59:17,640 --> 00:59:21,480
Speaker 1: lot of experience and knowledge. Away, I do see some

961
00:59:21,680 --> 00:59:24,120
Speaker 1: constraints while we're on the topic of you know, pluses

962
00:59:24,160 --> 00:59:29,000
Speaker 1: and minuses. One might be that these are civil servants,

963
00:59:29,040 --> 00:59:32,400
Speaker 1: and so what you describe is just a generic problem

964
00:59:32,640 --> 00:59:36,440
Speaker 1: among the civil service. So are there some rules related

965
00:59:36,440 --> 00:59:39,840
Speaker 1: to parity relating you know, GS scales and so on

966
00:59:40,280 --> 00:59:43,040
Speaker 1: that you would have to consider. I see, just the

967
00:59:43,120 --> 00:59:48,360
Speaker 1: way government workers are compensated has to be essentially universal

968
00:59:48,440 --> 00:59:54,040
Speaker 1: there or standardized. Yet in some way. A second issue

969
00:59:54,200 --> 00:59:57,160
Speaker 1: is just where that money would come from, because the

970
00:59:57,240 --> 01:00:01,240
Speaker 1: central source of conflicts actually, even with funding the f

971
01:00:01,400 --> 01:00:06,880
Speaker 1: d A is user fees, so basically requiring pharmaceutical companies

972
01:00:07,000 --> 01:00:09,440
Speaker 1: to pony up you know, hundreds of thousands of dollars

973
01:00:09,840 --> 01:00:13,800
Speaker 1: to finance the review process. Now it's not earmarks, so

974
01:00:13,920 --> 01:00:17,320
Speaker 1: that if visor submits a you know, drug for review,

975
01:00:17,720 --> 01:00:21,800
Speaker 1: that you know, people will necessarily favor the approval of

976
01:00:21,880 --> 01:00:24,920
Speaker 1: that drug. But financially the f d A and its

977
01:00:24,960 --> 01:00:29,120
Speaker 1: operations are funded in large part by pharmaceutical companies through

978
01:00:29,200 --> 01:00:32,600
Speaker 1: these user fees. I would consider that attacks in a

979
01:00:32,680 --> 01:00:36,439
Speaker 1: way of getting your product to market, and I think

980
01:00:36,520 --> 01:00:38,840
Speaker 1: that that makes sense. I mean, I do realize it

981
01:00:38,920 --> 01:00:44,120
Speaker 1: gives them a voice in the world of money and politics,

982
01:00:44,240 --> 01:00:49,040
Speaker 1: and so raising those fees probably would be unpopular with them.

983
01:00:49,440 --> 01:00:54,000
Speaker 1: I want to continue to talk about different conflicts of interest.

984
01:00:54,200 --> 01:00:56,920
Speaker 1: You wrote a chapter in a book called Conflicts of

985
01:00:57,080 --> 01:01:01,960
Speaker 1: Interest in FDA Advisory Committee that was eye opening for me.

986
01:01:02,880 --> 01:01:07,080
Speaker 1: Can you first just explain what an advisory committee is

987
01:01:07,200 --> 01:01:11,800
Speaker 1: and how that actually works. Sure, when a drug comes

988
01:01:11,920 --> 01:01:14,680
Speaker 1: up for approval, the f d A, you know, has

989
01:01:14,760 --> 01:01:18,880
Speaker 1: the final say, but oftentimes it doesn't have the internal

990
01:01:19,040 --> 01:01:23,360
Speaker 1: expertise or perhaps even the person hours to commit to

991
01:01:23,440 --> 01:01:26,680
Speaker 1: doing a full review of a particular drug, or you know,

992
01:01:26,760 --> 01:01:31,000
Speaker 1: the evidence is complicated and it needs external advice. So

993
01:01:31,560 --> 01:01:36,400
Speaker 1: frequently it convenes these advisory committees to review the application

994
01:01:36,560 --> 01:01:40,040
Speaker 1: for a particular drug. The people on these advisory committees

995
01:01:40,080 --> 01:01:44,000
Speaker 1: are not formally employees or full time employees of the

996
01:01:44,200 --> 01:01:49,120
Speaker 1: f d A. They are external experts. They're sitting at universities,

997
01:01:49,800 --> 01:01:55,960
Speaker 1: research institutes, think tanks, and they are physicians, researchers, some statisticians.

998
01:01:56,480 --> 01:01:58,680
Speaker 1: But one of the important things about this is if

999
01:01:58,720 --> 01:02:02,000
Speaker 1: you work for the government, there very clear ethics rules

1000
01:02:02,120 --> 01:02:06,480
Speaker 1: regarding your financial ties to industry. Um, if you were

1001
01:02:06,720 --> 01:02:09,000
Speaker 1: working at a university and then you get called on

1002
01:02:09,120 --> 01:02:12,360
Speaker 1: to be on these advisory committees, you know, these people

1003
01:02:12,400 --> 01:02:16,920
Speaker 1: sitting at universities have relationships with drug companies, They are

1004
01:02:16,960 --> 01:02:19,560
Speaker 1: consultants for them, they have their research funded by them.

1005
01:02:20,160 --> 01:02:23,320
Speaker 1: And so one of the things I looked at was

1006
01:02:23,880 --> 01:02:27,920
Speaker 1: whether the financial ties of these external experts who are

1007
01:02:28,000 --> 01:02:31,000
Speaker 1: called upon to advise whether a drug should be approved

1008
01:02:31,120 --> 01:02:34,280
Speaker 1: or not. Whether the financial ties of these experts had

1009
01:02:34,400 --> 01:02:39,360
Speaker 1: to drug companies was associated with whether they voted for

1010
01:02:39,560 --> 01:02:42,840
Speaker 1: approval of the drug or not, and how open they

1011
01:02:42,880 --> 01:02:45,760
Speaker 1: were to approval of the drug. Right, And it sounded

1012
01:02:45,800 --> 01:02:48,640
Speaker 1: to me like you had a specific hypothesis going into

1013
01:02:48,680 --> 01:02:51,680
Speaker 1: the work, which actually you even you were surprised by

1014
01:02:51,720 --> 01:02:55,480
Speaker 1: the results. Is that right? Yeah? So, I mean conventional wisdom,

1015
01:02:55,720 --> 01:02:59,440
Speaker 1: certainly in the ethics literature on conflicts of interest, which is,

1016
01:02:59,560 --> 01:03:02,520
Speaker 1: if you have, you know, when tied to industry, you know,

1017
01:03:02,680 --> 01:03:05,520
Speaker 1: that's not good. But if you have multiple ties, that's

1018
01:03:05,680 --> 01:03:10,160
Speaker 1: even more not good. That's like really really bad, yes, exactly.

1019
01:03:10,840 --> 01:03:13,960
Speaker 1: And then so we found two things. One was it

1020
01:03:14,120 --> 01:03:19,440
Speaker 1: turned out that when we compared how these experts voted,

1021
01:03:20,120 --> 01:03:23,720
Speaker 1: and we compared people who had one financial tie to

1022
01:03:23,840 --> 01:03:27,680
Speaker 1: those who had no financial ties. We actually found that

1023
01:03:28,480 --> 01:03:32,040
Speaker 1: people with a single financial tie to a company were

1024
01:03:32,080 --> 01:03:35,160
Speaker 1: more likely to vote in favor of the product sponsored

1025
01:03:35,360 --> 01:03:38,160
Speaker 1: by that company than people who had no financial ties.

1026
01:03:38,480 --> 01:03:40,640
Speaker 1: So there did to seem to be some bias, but

1027
01:03:40,760 --> 01:03:44,160
Speaker 1: it was only if you had a single financial tie

1028
01:03:44,240 --> 01:03:47,400
Speaker 1: to a company. In contrast, people who had a lot

1029
01:03:47,440 --> 01:03:50,160
Speaker 1: of financial ties, So people who had ties to murt

1030
01:03:50,360 --> 01:03:53,760
Speaker 1: Fiser lots of companies did not appear to vote any

1031
01:03:53,840 --> 01:03:57,400
Speaker 1: differently on average than people who had no financial ties.

1032
01:03:58,200 --> 01:04:00,760
Speaker 1: People with a lot of ties did not appear to

1033
01:04:00,800 --> 01:04:03,560
Speaker 1: be biased in how they voted, and so we talk

1034
01:04:03,600 --> 01:04:05,400
Speaker 1: a little bit about why that might be the case.

1035
01:04:06,080 --> 01:04:09,800
Speaker 1: One you know, hypothesis that makes sense to me is that,

1036
01:04:10,240 --> 01:04:11,600
Speaker 1: you know, a lot of times when people have a

1037
01:04:11,680 --> 01:04:14,919
Speaker 1: lot of financial ties, it's because they're really really good

1038
01:04:15,240 --> 01:04:17,480
Speaker 1: at what they do, and so a lot of companies

1039
01:04:17,520 --> 01:04:20,440
Speaker 1: want a piece of their brain. Um, it's not so

1040
01:04:20,560 --> 01:04:23,320
Speaker 1: they're not hiring these people so they could be hired

1041
01:04:23,400 --> 01:04:25,640
Speaker 1: guns to say what the company wants them to say.

1042
01:04:25,920 --> 01:04:28,400
Speaker 1: They're hiring these people because they're just really good at

1043
01:04:28,440 --> 01:04:31,200
Speaker 1: advising them. Yes, some of it is just they literally

1044
01:04:31,280 --> 01:04:35,560
Speaker 1: want great advice from smart people. But we did find

1045
01:04:35,680 --> 01:04:37,640
Speaker 1: some bias. I mean, I think the other thing that

1046
01:04:37,760 --> 01:04:40,040
Speaker 1: came out in the paper was that, you know, the

1047
01:04:40,160 --> 01:04:44,200
Speaker 1: type of conflict matters. So that hypothesis that I presented earlier,

1048
01:04:44,320 --> 01:04:47,240
Speaker 1: one tie is bad, many ties worse. It's sort of

1049
01:04:47,360 --> 01:04:50,640
Speaker 1: a the simplistic rule of film we had that doesn't

1050
01:04:50,680 --> 01:04:55,280
Speaker 1: acknowledge the fact that different kinds of ties matter for influence.

1051
01:04:55,720 --> 01:04:57,800
Speaker 1: And so the other thing we found was that it

1052
01:04:57,880 --> 01:05:01,960
Speaker 1: did not seem, for example, that experts who had ties

1053
01:05:02,560 --> 01:05:05,120
Speaker 1: through research funding so their research was funded by the

1054
01:05:05,200 --> 01:05:09,120
Speaker 1: drug company, were biased. But the kind of financial ties

1055
01:05:09,200 --> 01:05:12,680
Speaker 1: that really mattered were either you were you had an

1056
01:05:12,720 --> 01:05:16,200
Speaker 1: ownership stake in the company, you had some kind of

1057
01:05:16,280 --> 01:05:19,640
Speaker 1: stock in the company, which makes sense, and also a

1058
01:05:19,760 --> 01:05:22,200
Speaker 1: very strong effect came from whether you were on an

1059
01:05:22,240 --> 01:05:25,480
Speaker 1: advisory board for the company. Lots of times you may

1060
01:05:25,520 --> 01:05:27,840
Speaker 1: be on the board and you have a fiduciary responsibility

1061
01:05:28,400 --> 01:05:33,720
Speaker 1: for the company to act in uh interest right exactly. Yeah,

1062
01:05:33,800 --> 01:05:36,280
Speaker 1: that's a clear conflict like that that seems like that

1063
01:05:36,360 --> 01:05:38,440
Speaker 1: should be illegal. I mean, a lot of this should

1064
01:05:38,440 --> 01:05:40,920
Speaker 1: be illegal. To be honest, you would think it would,

1065
01:05:41,160 --> 01:05:43,800
Speaker 1: and if you read the rules, people who do have

1066
01:05:43,920 --> 01:05:47,920
Speaker 1: that kind of financial interest should not be participating in

1067
01:05:47,960 --> 01:05:51,400
Speaker 1: the advisory committees. But there is also a process that

1068
01:05:51,480 --> 01:05:55,200
Speaker 1: allows the FDA to make exceptions, and many times they

1069
01:05:55,240 --> 01:05:58,240
Speaker 1: make exceptions. And so you have people with these kinds

1070
01:05:58,280 --> 01:06:01,360
Speaker 1: of financial ties on these advisor committees, but things that

1071
01:06:01,440 --> 01:06:04,959
Speaker 1: don't matter, consulting research, you know, other kinds of ties

1072
01:06:05,000 --> 01:06:09,000
Speaker 1: don't matter. So I guess the paper was really advocating

1073
01:06:09,040 --> 01:06:13,200
Speaker 1: for more subtle policy related to conflicts of interests. Yeah,

1074
01:06:13,320 --> 01:06:16,480
Speaker 1: more disclosure, right, I mean, it seems like that should

1075
01:06:16,520 --> 01:06:20,240
Speaker 1: be fair if the FDA is tasked with, as it

1076
01:06:20,320 --> 01:06:24,280
Speaker 1: says on the website, above all else, safeguarding the health

1077
01:06:24,480 --> 01:06:27,040
Speaker 1: and well being of the American people. If that truly

1078
01:06:27,360 --> 01:06:33,000
Speaker 1: is above all else, then you know, you should have

1079
01:06:33,160 --> 01:06:36,880
Speaker 1: to disclose all of your financial ties. And it should

1080
01:06:36,880 --> 01:06:40,280
Speaker 1: be acknowledged that there are financial ties that are okay.

1081
01:06:40,560 --> 01:06:42,520
Speaker 1: In other words, if you're just being paid as an

1082
01:06:42,520 --> 01:06:45,600
Speaker 1: advisor for a company, and that's you being paid for

1083
01:06:45,680 --> 01:06:48,800
Speaker 1: your professional expertise, and that's fine. If you own a

1084
01:06:48,920 --> 01:06:52,880
Speaker 1: piece or you're on the on the board of one

1085
01:06:52,880 --> 01:06:55,400
Speaker 1: of the companies that's in question, that would disqualify you.

1086
01:06:55,800 --> 01:06:59,480
Speaker 1: And I don't understand why we can't enact rules like that.

1087
01:06:59,760 --> 01:07:03,400
Speaker 1: What would prevent us from from closing those loopholes? That's

1088
01:07:03,440 --> 01:07:07,000
Speaker 1: a great question. The two arguments that I've seen presented

1089
01:07:07,240 --> 01:07:12,520
Speaker 1: are that we would no longer be able to find

1090
01:07:12,800 --> 01:07:16,640
Speaker 1: people qualified enough to be on our advisory committees if

1091
01:07:16,680 --> 01:07:22,800
Speaker 1: we just outright banned the participation of people with financial ties,

1092
01:07:23,280 --> 01:07:26,200
Speaker 1: because all the all the really smart people are already

1093
01:07:26,480 --> 01:07:30,360
Speaker 1: on the take, essentially like or you know, whereas my

1094
01:07:30,400 --> 01:07:33,120
Speaker 1: study indicated, you know a lot of people want want

1095
01:07:33,160 --> 01:07:36,840
Speaker 1: a piece of their brains, so it would be difficult.

1096
01:07:37,120 --> 01:07:40,480
Speaker 1: And we can kind of see this because in the

1097
01:07:40,800 --> 01:07:44,520
Speaker 1: two thousands, the f d A in fact capped the

1098
01:07:44,600 --> 01:07:47,400
Speaker 1: exceptions that could be issued for people who had these

1099
01:07:47,520 --> 01:07:51,720
Speaker 1: kind of financial ties. Um So prior to this, the

1100
01:07:52,240 --> 01:07:55,480
Speaker 1: f d A issued just exceptions willy nilly and just

1101
01:07:55,600 --> 01:07:59,360
Speaker 1: basically said a lot of the apparently disqualifying financial interests

1102
01:07:59,720 --> 01:08:03,760
Speaker 1: did matter. In the two thousands, with one of the authorizations,

1103
01:08:04,040 --> 01:08:07,160
Speaker 1: the percentage of people who had these exceptions, and what

1104
01:08:07,320 --> 01:08:10,440
Speaker 1: you saw was of course a decline and people who

1105
01:08:10,520 --> 01:08:13,280
Speaker 1: had these exceptions in these financial ties. But what you

1106
01:08:13,440 --> 01:08:18,879
Speaker 1: also saw was more positions on the advisory committees being vacant,

1107
01:08:19,120 --> 01:08:21,799
Speaker 1: a longer time it would take to convene these advisory

1108
01:08:21,840 --> 01:08:24,120
Speaker 1: committees because they would need to spend more time to

1109
01:08:24,200 --> 01:08:29,000
Speaker 1: find people who are not conflicted. Yeah right, Yeah, I

1110
01:08:29,080 --> 01:08:32,120
Speaker 1: want to delve a little bit more into this idea

1111
01:08:32,439 --> 01:08:35,840
Speaker 1: of trust, because ultimately the FDA's job is to make

1112
01:08:36,000 --> 01:08:41,200
Speaker 1: us safe. And without guiding your answer at all, what

1113
01:08:41,439 --> 01:08:46,599
Speaker 1: needs to change so that we can trust the companies

1114
01:08:46,640 --> 01:08:48,920
Speaker 1: that are making our food and the companies that are

1115
01:08:49,000 --> 01:08:53,280
Speaker 1: making our drugs. What what about our system has to

1116
01:08:53,439 --> 01:08:56,320
Speaker 1: change to create more trust? I have to say I'm

1117
01:08:56,320 --> 01:08:59,320
Speaker 1: a little conflicted about this. I mean, the mission of

1118
01:08:59,360 --> 01:09:03,280
Speaker 1: the fd as pretty clear, you know, to ensure, among

1119
01:09:03,520 --> 01:09:05,560
Speaker 1: other things, to ensure the safety and efficacy of the

1120
01:09:05,640 --> 01:09:08,200
Speaker 1: drugs that are marketed in the US. The mission the

1121
01:09:08,240 --> 01:09:12,040
Speaker 1: drug companies is not that it is to make money

1122
01:09:12,120 --> 01:09:15,519
Speaker 1: for their shareholders, and so, you know, I do wonder

1123
01:09:15,760 --> 01:09:21,600
Speaker 1: whether it's realistic um to expect organizations whose objective is

1124
01:09:21,680 --> 01:09:25,839
Speaker 1: profitmaking to not do what they can do to make profits.

1125
01:09:26,240 --> 01:09:27,960
Speaker 1: But I like the way you framed it, because you

1126
01:09:28,040 --> 01:09:31,560
Speaker 1: framed it as a system, you know, not just the

1127
01:09:31,720 --> 01:09:33,600
Speaker 1: f d A. But I think the onus is on

1128
01:09:34,240 --> 01:09:39,680
Speaker 1: legislators policymakers to create rules that put guard rails on

1129
01:09:39,840 --> 01:09:44,479
Speaker 1: drug companies that still but that's still incentivize them to

1130
01:09:44,720 --> 01:09:47,840
Speaker 1: do the right thing. I think, as as you you

1131
01:09:47,960 --> 01:09:51,880
Speaker 1: might have framed it, so things that minimize gaming, how

1132
01:09:51,960 --> 01:09:55,560
Speaker 1: clinical trials are run and analyze, things that incentivize the

1133
01:09:55,600 --> 01:10:00,200
Speaker 1: collection of data on effectiveness and safety, and start the

1134
01:10:00,280 --> 01:10:03,080
Speaker 1: things that we want, which is quality information on safety

1135
01:10:03,120 --> 01:10:06,040
Speaker 1: and effectiveness with things that drug companies want, which is

1136
01:10:06,479 --> 01:10:13,120
Speaker 1: access to the market. Right, Okay, Genevieve, is there anything

1137
01:10:13,280 --> 01:10:18,519
Speaker 1: else that you think our our listeners should know about

1138
01:10:18,960 --> 01:10:21,960
Speaker 1: the f DA and things that either could or should change.

1139
01:10:22,479 --> 01:10:25,360
Speaker 1: I do think, you know, the problems we have with

1140
01:10:25,479 --> 01:10:28,479
Speaker 1: the f d A are structural. You know, there is

1141
01:10:28,520 --> 01:10:31,120
Speaker 1: that structural tension there about how can we get how

1142
01:10:31,160 --> 01:10:33,759
Speaker 1: can the agency have independence be based on the science,

1143
01:10:34,320 --> 01:10:37,639
Speaker 1: but you know, still have a commissioner that is serving

1144
01:10:37,680 --> 01:10:40,320
Speaker 1: at the pledgure of the president. The other structural tension

1145
01:10:40,600 --> 01:10:42,880
Speaker 1: and we see this, you know in our discussion as well,

1146
01:10:43,040 --> 01:10:45,960
Speaker 1: is you know, you can have an agency that approves

1147
01:10:46,520 --> 01:10:50,519
Speaker 1: drugs almost too fast, so they proved drugs that don't work,

1148
01:10:51,120 --> 01:10:54,240
Speaker 1: or you have safety issues, but you've increase access to

1149
01:10:54,320 --> 01:10:57,640
Speaker 1: the drug. But that's opposed to well that you know,

1150
01:10:57,720 --> 01:11:00,519
Speaker 1: the alternative is to have an agency that approves things

1151
01:11:00,600 --> 01:11:03,880
Speaker 1: too slowly, which is their drugs that it's preventing from

1152
01:11:03,920 --> 01:11:06,680
Speaker 1: being out on the market that people need to get

1153
01:11:06,680 --> 01:11:11,799
Speaker 1: access to. Right, we do need to have information systems

1154
01:11:11,840 --> 01:11:14,320
Speaker 1: that adapt an approval system that is adaptive in the

1155
01:11:14,400 --> 01:11:16,439
Speaker 1: same way that you know, all other systems in the

1156
01:11:16,479 --> 01:11:19,000
Speaker 1: world that we live in, you know, adapt to new information.

1157
01:11:19,280 --> 01:11:21,840
Speaker 1: And so hopefully that proposal and yours as well sort

1158
01:11:21,880 --> 01:11:24,439
Speaker 1: of adapts to you know, what we know and we

1159
01:11:24,479 --> 01:11:28,599
Speaker 1: can make better decisions that way. Okay, So last question

1160
01:11:29,320 --> 01:11:32,519
Speaker 1: on this podcast. We have a tool that we call

1161
01:11:32,600 --> 01:11:36,960
Speaker 1: the BS index, and the BS index measures the gap

1162
01:11:37,240 --> 01:11:41,360
Speaker 1: between word indeed, and it goes from zero to a hundred.

1163
01:11:41,600 --> 01:11:45,720
Speaker 1: Zero is the best score, So zero b s a

1164
01:11:45,840 --> 01:11:49,840
Speaker 1: hundred is the worst score total BS. And so the

1165
01:11:49,960 --> 01:11:54,280
Speaker 1: f d A today says that it strives above all

1166
01:11:54,520 --> 01:11:57,600
Speaker 1: else to safeguard the health and well being of the

1167
01:11:57,640 --> 01:12:02,439
Speaker 1: American people. What's or would you give the f d A.

1168
01:12:04,320 --> 01:12:09,439
Speaker 1: So I would say that my determined of the BA

1169
01:12:09,560 --> 01:12:14,160
Speaker 1: scores based on two main things that I think caused

1170
01:12:14,200 --> 01:12:16,040
Speaker 1: me to be worried about the f D A one

1171
01:12:16,160 --> 01:12:18,680
Speaker 1: is the degree of industry influence that leads it to

1172
01:12:19,640 --> 01:12:23,080
Speaker 1: diverge from its mission, as well as the degree to

1173
01:12:23,160 --> 01:12:26,360
Speaker 1: which it's vulnerable to political influence, you know, from the

1174
01:12:26,400 --> 01:12:31,360
Speaker 1: executive branch. Overall, I think the structure of the organization

1175
01:12:31,800 --> 01:12:38,400
Speaker 1: gives us generally reasonably high quality decisions. I would give

1176
01:12:38,479 --> 01:12:44,160
Speaker 1: it a forty five. Okay, that was great. Thank you

1177
01:12:44,280 --> 01:12:47,280
Speaker 1: so much for being here today, Jenny. I really appreciate it.

1178
01:12:47,960 --> 01:12:51,519
Speaker 1: Thank you for inviting me and having us think together

1179
01:12:51,800 --> 01:12:54,120
Speaker 1: about this issue. It was I really really had a

1180
01:12:54,160 --> 01:12:58,479
Speaker 1: great time. Thank you. All Right, folks, it's time for

1181
01:12:58,560 --> 01:13:02,719
Speaker 1: the FDA to get their fish'll b s score. Somehow

1182
01:13:02,800 --> 01:13:05,160
Speaker 1: feels appropriate that I try to get a little scientific

1183
01:13:05,280 --> 01:13:08,160
Speaker 1: with this one. So if I were to average our

1184
01:13:08,280 --> 01:13:12,400
Speaker 1: guest scores, the final score would be a forty eight. However,

1185
01:13:13,160 --> 01:13:17,280
Speaker 1: that still feels low to me, especially given Richard's account

1186
01:13:17,400 --> 01:13:20,559
Speaker 1: of basically being told to deliver the results his boss

1187
01:13:20,680 --> 01:13:24,160
Speaker 1: is wanted or risk losing his job at the agency.

1188
01:13:24,880 --> 01:13:28,360
Speaker 1: That's just plain scary. So I'm going to give the

1189
01:13:28,479 --> 01:13:31,920
Speaker 1: FDA a fifty five. I hope that acknowledges some of

1190
01:13:32,000 --> 01:13:36,040
Speaker 1: the agency's big winds over the years, but leaves plenty

1191
01:13:36,160 --> 01:13:40,439
Speaker 1: of room for some much needed improvement. And f d

1192
01:13:40,560 --> 01:13:44,120
Speaker 1: A Commissioner Robert Caliph, if you ever want to come

1193
01:13:44,160 --> 01:13:47,000
Speaker 1: on the show to discuss anything we've touched on today,

1194
01:13:47,439 --> 01:13:51,400
Speaker 1: please know that you have an open invitation. And if

1195
01:13:51,439 --> 01:13:54,280
Speaker 1: you're starting a purpose led business or thinking about beginning

1196
01:13:54,320 --> 01:13:57,360
Speaker 1: the journey of transformation to become one, here are three

1197
01:13:57,479 --> 01:14:04,559
Speaker 1: things you can take away from today's episod D One.

1198
01:14:05,800 --> 01:14:09,479
Speaker 1: Becoming purpose led is a big responsibility. It means that

1199
01:14:09,600 --> 01:14:13,519
Speaker 1: you're dedicating yourself to managing better outcomes for all of

1200
01:14:13,600 --> 01:14:18,560
Speaker 1: your stakeholders. That includes customers, employees, the community you do

1201
01:14:18,760 --> 01:14:23,000
Speaker 1: business in, and the planet. If all companies did that,

1202
01:14:23,400 --> 01:14:26,519
Speaker 1: we wouldn't need the f d A. The FDA only

1203
01:14:26,680 --> 01:14:31,360
Speaker 1: exists because the motivation to manage for maximum profitability is

1204
01:14:31,560 --> 01:14:35,639
Speaker 1: so powerful in our culture. The companies will knowingly sell

1205
01:14:35,720 --> 01:14:40,200
Speaker 1: products and services that damage people and the planet. Purpose

1206
01:14:40,320 --> 01:14:43,920
Speaker 1: Led companies win the trust of all their stakeholders by

1207
01:14:43,960 --> 01:14:47,880
Speaker 1: being transparent, by taking on problems they discover, and by

1208
01:14:48,040 --> 01:14:52,360
Speaker 1: solving them. They tend to do the right thing, even

1209
01:14:52,439 --> 01:14:57,120
Speaker 1: if it costs the money. Two. Once you know your purpose,

1210
01:14:57,400 --> 01:15:01,519
Speaker 1: take action against it. Since on. Fortunately, we do need

1211
01:15:01,600 --> 01:15:04,080
Speaker 1: the FDA to protect us from companies who would do

1212
01:15:04,240 --> 01:15:07,719
Speaker 1: us harm. The FDA needs to do a better job

1213
01:15:07,840 --> 01:15:11,920
Speaker 1: of that. The action idea that Genevieve brought today sticks

1214
01:15:12,000 --> 01:15:16,160
Speaker 1: with me. Any approval of any product is only conditional

1215
01:15:16,400 --> 01:15:19,519
Speaker 1: and time based and must be re reviewed once it's

1216
01:15:19,560 --> 01:15:21,840
Speaker 1: been in the market and we can all see the

1217
01:15:21,920 --> 01:15:26,400
Speaker 1: effects that it's actually having. That one change would help

1218
01:15:26,520 --> 01:15:29,240
Speaker 1: the f d A better live their purpose. What are

1219
01:15:29,280 --> 01:15:33,360
Speaker 1: the actions that you're taking to better live yours? Three?

1220
01:15:34,280 --> 01:15:38,520
Speaker 1: Simple is better. The f d A story is enormously

1221
01:15:38,680 --> 01:15:42,080
Speaker 1: complex because they cover such a broad waterfront and have

1222
01:15:42,320 --> 01:15:46,360
Speaker 1: so many stakeholders with so many different agendas. Define a

1223
01:15:46,560 --> 01:15:51,640
Speaker 1: simple reason why your company exists. Choose clarity and specificity

1224
01:15:51,840 --> 01:15:56,080
Speaker 1: over fluff. Solve a real problem, Do the right thing

1225
01:15:56,160 --> 01:15:59,880
Speaker 1: by your stakeholders, and keep doing that until you win.

1226
01:16:05,640 --> 01:16:08,919
Speaker 1: And if this episode made it through your approval process,

1227
01:16:09,320 --> 01:16:12,320
Speaker 1: subscribe to the Calling Bullshit podcast on the I Heart

1228
01:16:12,400 --> 01:16:15,920
Speaker 1: Radio app Apple Podcasts, where wherever you listen to people

1229
01:16:16,040 --> 01:16:19,240
Speaker 1: speaking to your ears and friends. I'd like to ask

1230
01:16:19,320 --> 01:16:22,679
Speaker 1: for your help. If you enjoy the Calling Bullshit podcast,

1231
01:16:22,840 --> 01:16:25,200
Speaker 1: please take a second to rate and review us on

1232
01:16:25,280 --> 01:16:29,920
Speaker 1: Apple podcasts or on your preferred platform. Thanks to our

1233
01:16:30,000 --> 01:16:34,679
Speaker 1: guests Lauren Edtter, Richard Williams, Gail Van Norman, and Genevieve Cantor.

1234
01:16:35,320 --> 01:16:37,639
Speaker 1: Learn more about them and get links to their work

1235
01:16:37,840 --> 01:16:41,360
Speaker 1: in our show notes, and many thanks to our production

1236
01:16:41,439 --> 01:16:46,800
Speaker 1: team Hannah bial, Amanda Ginsburg, d s Moss, Hailey, Pascalites,

1237
01:16:47,040 --> 01:16:52,000
Speaker 1: Parker Silzer, and Basil Soaper. Calling Bullshit was created by

1238
01:16:52,040 --> 01:16:54,680
Speaker 1: co Collective and it's hosted by me Ti Monting. You

1239
01:16:55,000 --> 01:17:01,719
Speaker 1: thanks for listening. Four